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1.  Balloon Kyphoplasty 
Executive Summary
Objective
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
Conclusion
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
2.  Capsular Contraction with S-Shaped Deformity of Nonlength-Expanding Inflatable Penile Prosthesis Cylinders: Management and Prevention Strategies 
Sexual Medicine  2013;1(2):95-98.
Introduction
Capsular contraction (CC) occurring with inflatable penile prosthesis (IPP) reservoirs has been reported by urologists as a cause of autoinflation. The concept of CC occurring around IPP cylinders has not been studied.
Aims
Herein we report a case of CC occurring with nonlength-expanding IPP cylinders, resulting in an S-shaped deformity.
Main Outcome Measures
We sought to report a novel cause of S-shaped deformity in patients after IPP surgery.
Methods
We reviewed a recent clinical case and conducted a literature review on capsular scar formation in prosthetic surgery. We also conducted a literature review of the inflammatory cascade related with prosthetic surgery.
Results
Capsular contracture of nonlength-expanding cylinders resulting in S-shaped deformity has not been previously reported. The role of certain inflammatory markers seems to play a common role of capsular contracture in the penis and other prosthetic implantation sites.
Conclusions
Capsular contractures around the cylinders of an IPP can cause deformity, even in patients who have appropriately sized, nonlength-expanding cylinders. A better understanding is needed regarding the mechanical properties of the tunica albuginea and the inflammatory cascade associated with penile implant surgery. This case represents an argument for early and aggressive postoperative inflation of the IPP. Future studies should evaluate the role of inflammation modulators as adjuvant therapy after IPP surgery. Karpman E and Henry G. Capsular contraction with S-shaped deformity of nonlength-expanding inflatable penile prosthesis cylinders: Management and prevention strategies. Sex Med 2013;1:95–98.
doi:10.1002/sm2.14
PMCID: PMC4184503  PMID: 25356293
Penile Prosthesis; S-Shaped Deformity; Capsular Contraction; Erectile Dysfunction; Penis; Surgery
3.  Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial 
Trials  2013;14:424.
Background
Breast reconstruction using the free muscle-sparing transversus abdominus myocutaneous or deep inferior epigastric perforator flaps are common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdominal donor site remains a major source of postoperative pain. Conventional postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side effects such as sedation, headache, nausea, vomiting, breathing difficulties and bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane peripheral nerve block.
Methods/Design
This study is a double-blind, placebo-controlled, randomized controlled trial designed to rigorously test the effectiveness of a transversus abdominis plane catheter delivering intermittent local anesthetic in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. The primary objective of this study is compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups including the patient-controlled anesthesia amounts and oral narcotic doses converted to intravenous morphine equivalent units. The secondary outcome measures include the following parameters: total in-hospital cumulative opioid consumption; daily patient-reported pain scores; total in-hospital cumulative anti-nausea consumption; nausea and sedation scores; and Quality of Recovery score; time to first bowel movement, ambulation, and duration of hospital stay.
Discussion
Autologous breast reconstruction using abdominal tissue is rapidly becoming the reconstructive option of choice for postmastectomy patients across North America. A substantial component of the pain experienced by patients after this abdominally based procedure is derived from the abdominal wall incision. By potentially decreasing the need for systemic opioids and their associated side effects, this transversus abdominis plane block study will utilize the most scientifically rigorous double-blind, placebo-controlled, randomized controlled trial methodology to potentially improve both clinical care and health outcomes in breast cancer surgery patients.
Trial registration
Clinicaltrials.gov NCT01398982
doi:10.1186/1745-6215-14-424
PMCID: PMC3878890  PMID: 24325953
Autologous abdominal tissue; Breast reconstruction; Donor site; Local pain block; Transversus abdominis plane catheter
4.  Anesthesia-Based Evaluation of Outcomes of Lower-Extremity Vascular Bypass Procedures 
Annals of vascular surgery  2012;27(2):199-207.
Background
This report examines the effects of regional versus general anesthesia for infrainguinal bypass procedures performed in the treatment of critical limb ischemia (CLI).
Methods
Nonemergent infrainguinal bypass procedures for CLI (defined as rest pain or tissue loss) were identified using the 2005 to 2008 American College of Surgeons National Surgical Quality Improvement Program database using International Classification of Disease, ninth edition, and Current Procedure Terminology codes. Patients were classified according to National Surgical Quality Improvement Program data as receiving either general anesthesia or regional anesthesia. The regional anesthesia group included those specified as having regional, spinal, or epidural anesthesia. Demographic, medical, risk factor, operative, and outcomes data were abstracted for the study sample. Individual outcomes were evaluated according to the following morbidity categories: wound, pulmonary, venous thromboembolic, genitourinary, cardiovascular, and operative. Length of stay, total morbidity, and mortality were also evaluated. Associations between anesthesia types and outcomes were evaluated using linear or logistic regression.
Results
A total of 5,462 inpatient hospital visits involving infrainguinal bypasses for CLI were identified. Mean patient age was 69 ± 12 years; 69% were Caucasian; and 39% were female. In all, 4,768 procedures were performed using general anesthesia and 694 with regional anes­thesia. Patients receiving general anesthesia were younger and significantly more likely to have a history of smoking, previous lower-extremity bypass, previous amputation, previous stroke, and a history of a bleeding diathesis including the use of warfarin. Patients receiving regional anesthesia had a higher prevalence of chronic obstructive pulmonary disease.
Tibial-level bypasses were performed in 51% of procedures, whereas 49% of procedures were popliteal-level bypasses. Cases performed using general anesthesia demonstrated a higher rate of resident involvement, need for blood transfusion, and operative time. There was no difference in the rate of popliteal-level and infrapopliteal-level bypasses between groups. Infrapopliteal bypass procedures performed using general anesthesia were more likely to involve prosthetic grafts and composite vein. Mortality occurred in 157 patients (3%). The overall morbidity rate was 37%. Mean and median lengths of stay were 7.5 days (±8.1) and 6.0 days (Q1: 4.0, Q3: 8.0), respectively. Multivariate analyses demonstrated no significant differences by anesthesia type in the incidence of morbidity, mortality, or length of stay.
Conclusion
These results provide no evidence to support the systematic avoidance of general anesthesia for lower-extremity bypass procedures. These data suggest that anesthetic choice should be governed by local expertise and practice patterns.
doi:10.1016/j.avsg.2012.04.006
PMCID: PMC4279240  PMID: 22944010
5.  Greek surgical patients’ satisfaction related to perioperative anesthetic services in an academic institute 
Background
Patient satisfaction is an increasingly appreciated measure of outcome for health care procedures. The purpose of this study was to evaluate Greek surgical patients’ satisfaction with perioperative anesthetic services and to determine which factors maximize satisfaction level through all phases of perioperative care.
Methods
Adult Greek patients admitted for elective surgery in an academic hospital were included in the study. Three separate questionnaires were constructed: Q1 (patients who underwent general anesthesia alone or combined with epidural) and Q2 (patients who received regional anesthesia alone) covered perioperative anesthetic care; Q3 covered postoperative analgesia services in the ward (patient-controlled analgesia or epidural analgesia) provided by our anesthesiologist-centered analgesia care team. Principal component analysis with varimax rotation was used separately for each questionnaire, and extracted factors were entered into multiple logistic regression with patient satisfaction as the dependent binary variable. Statistical significance level was set at P < 0.05.
Results
Three hundred and forty-five patients were included. Q1 questionnaire (answered by 282 patients) included four dimensions: communication with the anesthesiologist, sense of cold/shivering, pain, and nausea. Q2 questionnaire (answered by 63 patients) included three dimensions: communication with the anesthesiologist, sense of cold/shivering, and nausea/anxiety. Q3 questionnaire (answered by 237 patients) included five dimensions: anesthesiologist intervention upon symptoms, pain, care by the anesthesiologist/physical activity, nausea/vomiting, and anesthesiologist behavior. The communication dimension score in Q1 and Q2, sense of shivering in Q2, and pain management and anesthesiologist behavior dimension scores in Q3 were significantly associated with patient satisfaction. Overall satisfaction rates were high (according to the questionnaire, the observed percentage was in the range of 96.3%–98.6%).
Conclusion
Greek surgical patients reported high satisfaction with perioperative anesthesia care. Interaction between patient and anesthesiologists during all periods of study, absence of shivering in regional anesthesia, and adequate postoperative pain control in the ward were significant predictors of patient satisfaction in the present Greek surgical population.
doi:10.2147/PPA.S34244
PMCID: PMC3422116  PMID: 22927750
Greek surgical patients; satisfaction; questionnaire; anesthetic management; postoperative analgesia care team
6.  Penile prostheses 
Penile prosthesis implantation is recognized as a valid option to obtain an artificial erection satisfactory for sexual intercourse in those patients in which a pharmacological approach is contraindicated or ineffective. Penile prostheses are subbject to continuous development and they are achieving ever better mechanical reliability and safety. The devices are divided into two general types: semirigid (malleable and mechanical) and inflatables. The AMS® (American Medical Systems) and Coloplast Ltd® produce the majority of inflatable and semirigid devices.
Malleable and mechanical prostheses have the disadvantage that the penis is always erect although it can be orientated in different ways, while the advantages are ease of use and the need for a simpler surgical procedure compared with inflatable prostheses. Three-component prostheses are more sophisticated than semirigid devices. The advantages of these devices are that the prosthesis feels softer than semirigid or two-piece devices when deflated, with a better cosmetic result, and it ensures a more natural erection than others kinds of prosthesis. The disadvantages are the possibility of malfunction and the need for a more complicated surgical technique. Implantation of a penile prosthesis can be performed in a short surgical time under locoregional anaesthesia, and for this reason hospitalization is usually brief and the patient can be discharged 2 days after the operation if complications are not evident. Patient and partner satisfaction reflect the quality and the effectiveness of this treatment. Even though the results are positive in the vast majority of patients, the possibility of several complications makes penile prosthesis implantation a delicate kind of surgery. Complications can happen when the operation is carried out, in the peri-operative and in the postoperative period, and include infections, erosions of the prosthesis and mechanical failure in case of inflatable prosthesis. Penile prostheses available on the market have improved the success of this kind of surgery, thanks to the introduction of new materials and designs.
doi:10.1177/1756287209359174
PMCID: PMC3126066  PMID: 21789081
penile prosthesis; erectile dysfunction; inflatable prosthesis; semirigid prosthesis
7.  Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study 
Background:Clinical effects, recovery characteristics, and costs of total intravenous anesthesia with different inhalational anesthetics have been investigated and compared; however, there are no reported clinical studies focusing on the effects of anesthesia with propofol and desflurane in patients undergoing laparoscopic cholecystectomy.
Objective: The aim of this study was to determine the effects of total intravenous anesthesia with propofol and alfentanil compared with those of desflurane and alfentanil on recovery characteristics, postoperative nausea and vomiting (PONV), duration of hospitalization, and gastrointestinal motility.
Methods: Patients classified as American Society of Anesthesiologists physical status I or II undergoing elective laparoscopic cholecystectomy due to benign gallbladder disease were enrolled in the study. Patients were randomly assigned at a 1:1 ratio to receive total intravenous anesthesia with propofol (2–2.5 mg/kg) and alfentanil (20 μg/kg) or desflurane (4%–6%) and alfentanil (20 μg/kg). Perioperative management during premedication, intraoperative analgesia, relaxation, ventilation, and postoperative analgesia were carried out identically in the 2 groups. Extubation time, recovery time, PONV, postoperative antiemetic requirement, time to gastrointestinal motility and flatus, duration of hospitalization, and adverse effects were recorded. Postoperative pain was assessed using a visual analogue scale.
Results: Sixty-eight patients were assessed for inclusion in the study; 5 were excluded because they chose open surgery and 3 did not complete the study because they left the hospital. Sixty patients (33 women, 27 men) completed the study. Recovery time was significantly shorter in the propofol group (n = 30) compared with the desflurane group (n = 30) (8.0 [0.77] vs 9.2 [0.66] min, respectively; P < 0.005). Fifteen patients (50.0%) in the propofol group and 20 patients (66.7%) in the desflurane group experienced nausea during the first 24 hours after surgery. The difference was not considered significant. In the propofol group, significantly fewer patients had vomiting episodes compared with those in the desflurane group (2 [6.7%] vs 16 [53.3%]; P < 0.005). Significantly fewer patients in the propofol group required analgesic medication in the first 24 hours after surgery compared with those in the desflurane group (10 [33.3%] vs 15 [50.0%]; P < 0.005). Patients in the propofol group experienced bowel movements in a significantly shorter period of time compared with patients in the desflurane group (8.30 [1.67] vs 9.76 [1.88] hours; P = 0.02). The mean time to flatus occurred significantly sooner after surgery in the propofol group than in the desflurane group (8.70 [1.79] vs 9.46 [2.09] hours; P = 0.01). The duration of hospitalization after surgery was significantly shorter in the propofol group than in the desflurane group (40.60 [3.49] vs 43.60 [3.56] hours; P = 0.03).
Conclusion: Total intravenous anesthesia with propofol and alfentanil was associated with a significantly reduced rate of PONV and analgesic consumption, shortened recovery time and duration of hospitalization, accelerated onset of bowel movements, and increased patient satisfaction compared with desflurane and alfentanil in these patients undergoing laparoscopic surgery who completed the study.
doi:10.1016/j.curtheres.2009.04.002
PMCID: PMC3967343  PMID: 24683221
total intravenous anesthesia; propofol; desflurane; alfentanil; laparoscopic cholecystectomy
8.  Suprapubic Cystostomy for the Management of Urethral Injuries During Penile Prosthesis Implantation 
Sexual Medicine  2014;2(4):178-181.
Introduction
Urethral injury is an uncommon surgical complication of penile prosthesis (PP) surgery. Conventional dogma requires abortion of the procedure if the adjacent corporal body is involved or delayed implantation to avert device infection associated with urinary extravasation. Besides the setback of the aborted surgery, this management approach also presents the possible difficulty of encountering corporal fibrosis at the time of reoperation.
Aim
We report an approach using primary urethral repair and temporary suprapubic cystostomy for the management of incidental urethral injuries in a cohort of patients allowing for successful completion of unaborted PP implantation.
Materials and Methods
We performed a retrospective analysis of all patients receiving PPs from 1990 to 2014 in which incidental urethral injuries were repaired and PP implantation was completed with suprapubic cystostomy (suprapubic tube [SPT] insertion). After allowing for urethral healing and urinary diversion via SPT for 4–8 weeks, the PP was activated.
Main Outcome Measures
Successful management was determined by the absence of perioperative complications within 6 months of implantation.
Results
We identified four cases, all receiving inflatable PPs, managed with temporary suprapubic cystostomy. These patients sustained urethral injuries during corporal dissection (one patient), corporal dilation (one patient), and penile straightening (two patients). All patients were managed safely and successfully.
Conclusion
Primary urethral repair followed by temporary suprapubic cystostomy offers a surgical approach to complete PP implantation successfully in patients who sustain urethral injury complications, particularly for complex PP surgeries. Anele UA, Le BV, and Burnett AL. Suprapubic cystostomy for the management of urethral injuries during penile prosthesis implantation.
doi:10.1002/sm2.44
PMCID: PMC4272249  PMID: 25548649
Penile Reconstruction; Penile Fibrosis; Corporal Dilation; Erectile Dysfunction; SPT
9.  Penile block for paediatric urological surgery: A comparative evaluation with general anaesthesia 
Aim:
Peri-operative pain relief in children can be provided by conventional general anaesthesia or by regional nerve blocks. The present study was carried out to evaluate and compare the effectiveness of penile block for penile surgery with the standard technique of general anaesthesia (GA) of short duration of less than two hours, and also to evaluate the postoperative pain relief obtained by penile block.
Materials and Methods:
The study was carried out in the department of Anaesthesiology and Intensive care of our hospital, on 60 children in the age group of 1-10 years, belonging to American Society of Anesthesiologists (ASA) grades I and II, and divided randomly into two groups: Group B and group G, comprising of 30 patients each. Group B children received a penile block whereas group G children underwent a standard general anaesthetic procedure. Baseline, intra-operative and post-operative heart rate (HR), electrocardiogram (ECG), non-invasive blood pressure (NIBP) (systolic and diastolic) and pulse oximeter oxygen saturation (SpO2) were recorded at regular intervals. The duration of post-operative pain relief, time to rescue analgesia and time to first feed were also evaluated and recorded. Statistical analysis was carried out using statistical package for social sciences (SPSS) 11 version for windows and employing analysis of variance (ANOVA), unpaired student t test, Chi-square test and Mann Whitney U test for various parameters. Value of P<0.05 was considered as significant and P<0.0001 as highly significant.
Results:
The demographic characteristics were comparable in both the groups. Heart rate, systolic blood pressure, diastolic blood pressure and pulse oximetry showed remarkable differences at various time intervals during intra-operative and post-operative period, which were statistically significant on comparison (P<0.05 and P<0.0001). Post-operative pain relief, time to first rescue analgesia and time to first feed also showed statistically significant differences.
Conclusions:
Penile block is very effective when used along with light sedation for distal penile surgeries of less than 2 hours duration as compared to standard GA as reflected by more stable haemodynamics in peri-operative period, excellent pain relief extending up to 6-8 hrs postoperatively and absence of any significant complications or side effects.
doi:10.4103/0970-1591.91432
PMCID: PMC3263211  PMID: 22279309
Bupivacaine; general anaesthesia; penile block; penile surgery
10.  A comparison of femoral/sciatic nerve block with lateral femoral cutaneous nerve block and combined spinal epidural anesthesia for total knee replacement arthroplasty 
Korean Journal of Anesthesiology  2012;62(5):448-453.
Background
Several factors, such as compromised cardiopulmonary function, anticoagulative therapy, or anatomical deformity in the elderly, prevent general anesthesia and neuraxial blockade from being conducted for total knee replacement arthroplasty (TKRA). We investigated the efficacy of femoral/sciatic nerve block with lateral femoral cutaneous nerve block (FSNB) as an alternative procedure in comparison with combined spinal epidural nerve block (CSE) in patients undergoing TKRA.
Methods
In this observational study, 80 American Society of Anesthesiologists physical status I-III patients scheduled for elective unilateral TKRA underwent CSE (n = 40) or FSNB (n = 40). Perioperative side effects, intraoperative medications, duration and remaining amount of intravenous patient-controlled analgesia, rate of satisfaction with the surgical anesthesia and postoperative analgesia, willingness to recommend the same surgical anesthesia and postoperative analgesia to others, and postoperative visual analog scale pain scores were assessed. Statistical analysis was done using Chi-square test, Student's t-test, and repeated-measures analysis of variances.
Results
There was significantly more use of antihypertensives, analgesics, and sedatives in the FSNB group. There were no significant differences of perioperative side effects, duration and remaining amount of intravenous patient-controlled analgesia, rate of satisfaction with the surgical anesthesia and postoperative analgesia, willingness to recommend the same surgical anesthesia and postoperative analgesia to others, and postoperative visual analog scale scores between the two groups.
Conclusions
FSNB with a sophisticated use of antihypertensives, analgesics, and sedatives to supplement insufficient block offers a practical alternative to CSE for TKRAs.
doi:10.4097/kjae.2012.62.5.448
PMCID: PMC3366312  PMID: 22679542
Epidural anesthesia; Femoral nerve; Nerve block; Sciatic nerve; Spinal anesthesia; Total knee replacement
11.  Comparison of Two Clinical Protocols for Total Intravenous Anesthesia (TIVA) for Breast Surgery Using Propofol Combined With Either Sufentanil or Alfentanil 
Background:
Sufentanil and alfentanil have pharmacokinetic and dynamic properties which make them favourable substances for total intravenous anesthesia (TIVA) in combination with propofol.
Objectives:
We planned to compare two clinical protocols for TIVA with propofol, and either sufentanil or alfentanil in regards to postoperative pain, hemodynamic stability during the case and time for emergence from anesthesia.
Patinets and Methods:
Treaty eight patients scheduled for general anesthesia for breast surgery were included in this Double-blind, randomized, controlled trial. All patients received a standardized TIVA with propofol and either 0.2 µg kg-1 sufentanil or 20 µg kg-1 alfentanil for induction and 0.3 µg kg-1 h-1 sufentanil or 30 µg kg-1 h-1 alfentanil for maintenance with additional propofol boluses as needed. During anesthesia, heart rate, non-invasive blood-pressure, peripheral oxygen saturation and depth of anesthesia, were recorded. In the post anesthesia care unit, pain scores, nausea and vomiting as well as medications were recorded.
Results:
Patients in the sufentanil group required less often additional opioid and propofol boluses to maintain adequate anesthesia. We did not observe a significant difference in time to extubation. Postoperatively, patients in the sufentanil group had less pain (P = 0.03) and required less i.v. opioids (0.4 vs. 1.9 mg piritramid, P = 0.04).
Conclusions:
Both protocols provide excellent anesthesia, but patients receiving sufentnail had more stable anesthesia and less postoperative pain.
doi:10.5812/aapm.19278
PMCID: PMC4199218  PMID: 25337474
Intravenous Anesthesia; Pharmacokinetics; Postoperative Pain; Sufentanil; Alfentanil
12.  Postoperative nausea and vomiting after endoscopic thyroidectomy: total intravenous vs. balanced anesthesia 
Korean Journal of Anesthesiology  2011;60(6):416-421.
Background
Endoscopic thyroidectomy was recently introduced and has been rapidly accepted by surgeons and patients. The present study was conducted to estimate and compare the incidences of postoperative nausea and vomiting (PONV) after endoscopic thyroidectomy using two different anesthetic methods: sevoflurane based balanced anesthesia; total intravenous anesthesia (TIVA).
Methods
Ninety nine female patients that were scheduled to undergo elective endoscopic thyroidectomy under general anesthesia were enrolled. These patients were randomly allocated to receive sevoflurane based balanced anesthesia (BA group) or propofol-remifentanil anesthesia (TIVA group). PONV was evaluated using a 4-point Likert scale, and pain using a visual analogue scale (VAS; range 0 to 100) for 0-2, 2-6, and 6-24 hours postoperatively. At 24 hours postoperatively, overall patient satisfaction regarding PONV and pain were recorded.
Results
The incidence of PONV was 14.6% in the TIVA group and 51.3% in the BA group. The incidence of nausea at 0-2 and 2-6 hours postoperatively was lower in the TIVA group than in the BA group (4.2% vs. 35.9%, 6.3% vs. 23.1%, respectively), but no between-group difference was observed at 6-24 hours postoperatively (8.3% vs. 5.1%). Antiemetic usage at 0-2 and 2-6 hours was lower in the TIVA than the BA group (4.2% vs. 38.5%, 6.3% vs. 23.1%), but no between-group difference was observed for 6-24 hours (6.3% vs. 7.7%). There were no differences in pain or in patient satisfaction.
Conclusions
After endoscopic thyroidectomy, total intravenous anesthesia with propofol-remifentanil is associated with less PONV during the early postoperative period (0-6 hours) than sevoflurane based balanced anesthesia.
doi:10.4097/kjae.2011.60.6.416
PMCID: PMC3121088  PMID: 21738844
Endoscopic surgery; PONV; Thyroidectomy
13.  Anesthetic implications of laparoscopic surgery. 
Minimally invasive therapy aims to minimize the trauma of any interventional process but still achieve a satisfactory therapeutic result. The development of "critical pathways," rapid mobilization and early feeding have contributed towards the goal of shorter hospital stay. This concept has been extended to include laparoscopic cholecystectomy and hernia repair. Reports have been published confirming the safety of same day discharge for the majority of patients. However, we would caution against overenthusiastic ambulatory laparoscopic cholecystectomy on the rational but unproven assumption that early discharge will lead to occasional delays in diagnosis and management of postoperative complications. Intraoperative complications of laparoscopic surgery are mostly due to traumatic injuries sustained during blind trocar insertion and physiologic changes associated with patient positioning and pneumoperitoneum creation. General anesthesia and controlled ventilation comprise the accepted anesthetic technique to reduce the increase in PaCO2. Investigators have recently documented the cardiorespiratory compromise associated with upper abdominal laparoscopic surgery, and particular emphasis is placed on careful perioperative monitoring of ASA III-IV patients during insufflation. Setting limits on the inflationary pressure is advised in these patients. Anesthesiologists must maintain a high index of suspicion for complications such as gas embolism, extraperitoneal insufflation and surgical emphysema, pneumothorax and pneumomediastinum. Postoperative nausea and vomiting are among the most common and distressing symptoms after laparoscopic surgery. A highly potent and selective 5-HT3 receptor antagonist, ondansetron, has proven to be an effective oral and IV prophylaxis against postoperative emesis in preliminary studies. Opioids remain an important component of the anesthesia technique, although the introduction of newer potent NSAIDs may diminish their use. A preoperative multimodal analgesic regimen involving skin infiltration with local anesthesia. NSAIDs to attenuate peripheral pain and opioids for central pain may reduce postoperative discomfort and expedite patient recovery/discharge. There is no conclusive evidence to demonstrate clinically significant effects of nitrous oxide on surgical conditions during laparoscopic cholecystectomy or on the incidence of postoperative emesis. Laparoscopic cholecystectomy has proven to be a major advance in the treatment of patients with symptomatic gallbladder disease.
PMCID: PMC2578944  PMID: 10604786
14.  Penile prosthesis implantation in Chinese patients with severe erectile dysfunction: 10-year experience 
Asian Journal of Andrology  2013;15(5):658-661.
We retrospectively evaluated the clinical outcome of penile prosthesis implantation (PPI) in Chinese patients with severe erectile dysfunction (SED). From July 2000 to December 2011, 224 patients (mean age: 35.9±11.8 years, range: 20–75 years) with SED underwent PPI by experienced surgeon according to standard PPI procedure at our centre. A malleable prosthesis (AMS 650) was implanted in 45 cases (20.1%), and a three-piece inflatable prosthesis (AMS 700 CXM or AMS 700 CXR) was implanted in 179 cases (79.9%). Surgical outcomes, including postoperative complications, clinical efficacy and couple satisfaction, were evaluated over than 6 months postoperatively using medical record abstraction, IIEF-5, quality of life (QoL) scores, and the patient/partner sexual satisfaction score proposed by Bhojwani et al. Of the 224 patients eligible for the study, 201 subjects (89.7%) completed follow-up. All of patients could perform sexual intercourse post PPI with the mean postoperative IIEF-5 and QoL scores were 20.02±2.32 and 5.28±0.76, respectively, which were significantly improved compared with the preoperative scores (6.29±1.5 and 2.13±0.84, P<0.01). Of the 201 men, mechanical malfunction occurred in four cases (2.0%) and three cases were re-implanted new device, and two cases (1.0%) developed a mild curvature of the penis. Scrotal erosion with infection occurred in one case with diabetes mellitus (0.5%) and required complete removal of the implanted AMS 700 CXM. Satisfactory sexual intercourse at least twice per month was reported by 178 men (88.6%), and overall satisfaction with the PPI surgery was reported by 89.0% of men and 82.5% of partners. Patient satisfaction in the three-piece inflatable prosthesis group was higher than in the malleable prosthesis group (P<0.05). Satisfaction, however, between the types of prostheses, did not differ in the partner survey. PPI is a safe and effective treatment option for Chinese patients with SED and experienced surgeon perform PPI according to standard PPI procedure could reduce the postoperative complications of PPI and could improve patient satisfaction ratio and QoL.
doi:10.1038/aja.2013.78
PMCID: PMC3881644  PMID: 23872664
complication; erectile dysfunction (ED); implantation; quality of life (QoL); penile prosthesis; satisfaction
15.  Analgesic efficacy of peritubal infiltration of ropivacaine versus ropivacaine and morphine in percutaneous nephrolithotomy under ultrasonic guidance 
Saudi Journal of Anaesthesia  2013;7(2):118-121.
Background and Purpose:
Percutaneous nephrolithotomy is a safe and effective endourologic procedure which is less morbid than open surgery. However, pain around a nephrostomy tube requires good post-operative analgesia. We hypothesize that infiltration of local anesthetic with opioid from the renal capsule to the skin around the nephrostomy tract under ultrasonic guidance would alleviate the postoperative pain for a long period.
Methods:
A total of 60 ASA physical status I to II patients were selected for a prospective randomized double-blind controlled study in percutaneous nephrolithotomy surgeries. Patients were divided into group R (n=30) and group RM (n=30). Balanced general anesthesia was given. After completion of the surgical procedure, a 23-gauze spinal needle was inserted at 6 and 12 O’clock position under ultrasonic guidance up to renal capsule along the nephrostomy tube. A 10 ml drug solution was infiltrated in each tract while withdrawing from renal capsule to the skin. After extubation, the patient was shifted to the post-anesthesia care unit for 24 hours. Post-operative pain was assessed using the visual analog scale (VAS) and dynamic visual analog scale (DVAS) (during deep breathing and coughing) rating 0-10 for initial 24 hours. Rescue analgesia was given in the form of injection tramadol 1.0 mg/kg intravenously when VAS ≥4 and maximum up to 400 mg in 24 hours. Time to 1st rescue analgesic, number of doses of tramadol and total consumption of tramadol required in initial 24 hours were noted. Patients were observed for any side effect and treated accordingly.
Results:
Time to 1st rescue analgesic, i.e., duration of analgesia in group RM is more prolonged than group R (P=0.0004). The number of doses of tramadol in 24 hours in group R were higher as compared to group RM (P=0.0003). The total amount of tramadol in 24 hours in group R was more than in group RM (P=0.0013). Side effects like nausea and vomiting and sedation were comparable in both the groups.
Conclusion:
Addition of morphine to ropivacaine for nephrostomy tract infiltration significantly prolonged the duration of post-operative analgesia and reduced the number of doses and total consumption of rescue analgesic in initial 24 hours in percutaneous nephrolithotomy surgery.
doi:10.4103/1658-354X.114046
PMCID: PMC3737683  PMID: 23956707
Morphine; percutaneous nephrolithotomy; ropivacaine; ultrasound
16.  Parental Recall of Anesthesia Information: Informing the Practice of Informed Consent 
Anesthesia and analgesia  2011;112(4):918-923.
Background
Informed consent is a process of sharing information that facilitates the individual patient’s right to self-determination. Despite its importance in anesthesia practice, the process of informed consent is rarely audited or examined. As such, there are only limited data with respect to anesthesia consent practices particularly within the pediatric setting. We designed this study, therefore, to examine the information that parents seek regarding their child’s anesthesia, what they are told, who told them, and how much of the information they recall.
Methods
Parents of children undergoing a variety of elective surgical procedures were recruited while their child was in surgery. Parents were interviewed to determine their recall of their child’s anesthetic plan, postoperative pain management, and attendant risks and benefits; and then surveyed regarding what information was sought and received, and how satisfied they were with the information.
Results
Two hundred sixty-three parents were included. Although the majority (96.2%) recalled receiving information about how their child’s anesthesia would be administered, only 51.1% recalled being given information about the risks of anesthesia and 42.4% how side effects would be managed. Composite scores for parental recall of anesthesia information were generally poor (4.9 ± 2.5 out of 10). Furthermore, 50% and 55.7% of parents had no recall of the risks or benefits of anesthesia, respectively, and 82.9% could not recall pain medication side effects. Recall of consent information obtained by anesthesia providers was significantly better than when obtained by surgical personnel (P <0.01).
Conclusions
Results showed that disclosure of anesthesia information to parents was often incomplete, and their recall thereof, poor. The finding that recall of consent information provided by anesthesia providers was better than when provided by surgical personnel may serve to further the debate regarding the appropriate vehicles for anesthesia consent.
doi:10.1213/ANE.0b013e31820a9193
PMCID: PMC3073673  PMID: 21288976
17.  Does dexamethasone prevent subarachnoid meperidin-induced nausea, vomiting and pruritus after cesarean delivery? 
Saudi Journal of Anaesthesia  2013;7(2):138-141.
Background:
Opioid-induced side effects such as nausea and vomiting and pruritus are common and may be more debilitating than pain itself. We performed a study to assess the efficacy of dexamethasone in reducing postoperative nausea, vomiting, and pruritus in patients receiving neuraxial anesthesia with meperidine.
Methods:
Fifty-two women undergoing cesarean section were enrolled in the study. The control group and dexamethasone group received intravenously normal saline and dexamethasone, respectively, before spinal anesthesia. The occurrence of postoperative nausea, vomiting, and pruritus was assessed for 24 h in both groups.
Results:
The overall incidence of nausea and vomiting during the 24 h follow-up period was 37% and 22.2% for group saline and 20% and 12% for group dexamethasone, respectively (P=0.175, 0.469). The incidence of pruritus was not significantly different between the two groups. Pruritus severity was significantly less in the dexamethasone group than in the saline group (P=0.019).
Conclusion:
Prophylactic dexamethasone does not reduce the incidence of subarachnoid meperidine-induced nausea, vomiting, and pruritus in women undergoing cesarean delivery.
doi:10.4103/1658-354X.114057
PMCID: PMC3737687  PMID: 23956711
Cesarean delivery; meperidine; nausea and vomiting; pruritus; spinal anesthesia
18.  Does Ramosetron Reduce Postoperative Emesis and Pain after TKA? 
Background
Current pain management protocols involving many anesthetic and analgesic drugs reportedly provide adequate analgesia after TKA. However, control of emetic events associated with the drugs used in current multimodal pain management remains challenging.
Questions/purposes
We determined (1) whether ramosetron prophylaxis reduces postoperative emetic events; and (2) whether it influences pain levels and opioid consumption in patients managed with a current multimodal pain management protocol after TKA.
Methods
We randomized 119 patients undergoing TKA to receive either ramosetron (experimental group, n = 60) or no prophylaxis (control group, n = 59). All patients received regional anesthesia, preemptive analgesic medication, continuous femoral nerve block, periarticular injection, and fentanyl-based intravenous patient-controlled analgesia. We recorded the incidence of emetic events, rescue antiemetic requirements, complete response, pain level, and opioid consumption during three periods (0–6, 6–24, and 24–48 hours postoperatively). The severity of nausea was evaluated using a 0 to 10 VAS.
Results
The ramosetron group tended to have a lower incidence of nausea with a higher complete response and tended to have less severe nausea and fewer rescue antiemetic requirements during the 6- to 24-hour period. However, the overall incidences of emetic events, rescue antiemetic requirements, and complete response were similar in both groups. We found no differences in pain level or opioid consumption between the two groups.
Conclusions
Ramosetron reduced postoperative emetic events only during the 6- to 24-hour postoperative period and did not affect pain relief. More efficient measures to reduce emetic events after TKA should be explored.
Level of Evidence
Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-011-2208-0
PMCID: PMC3348324  PMID: 22161082
19.  Comparing the Duration of the Analgesic Effects of Intravenous and Rectal Acetaminophen Following Tonsillectomy in Children 
Background:
Postoperative pain control (especially, after adenotonsillectomy) has a very important effect on recovery time, hospitalization duration, hemodynamic disorders, bleeding, nausea, vomiting and medical costs.
Objectives:
The aim of this study was to investigate and compare the effects of intravenous and rectal acetaminophen on controlling post-adenotonsillectomy pain in children, and duration of their analgesic effects.
Patients and Methods:
In this randomized double-blinded clinical trial, 96 children aged 4 - 10 years old with ASA physical status I or II who were candidates for adenotonsillectomy surgery in Amir-al-Momenin Hospital, Rasht, Iran were entered into the study and randomly divided into two equal groups. Anesthesia in both groups was induced injecting fentanyl-thiopental and at racurium; afterwards is of lurane was used to maintain anesthesia. After anesthesia induction, one group received intravenous and the other one, rectal acetaminophen, and were later compared based on CHIPPS criteria.
Results:
Data analysis indicated a significant relationship between reduction of postoperative pain and the use of intravenous or rectal acetaminophen (P = 0.0001); in group receiving IV acetaminophen, only 10.4% of patients had no pain whereas in group receiving rectal acetaminophen, this number reached 43.8%. Also, on 4 and 6 hour time intervals, pain in rectal acetaminophen receiving group was less than that in IV acetaminophen receiving group (P < 0.05). Demand for additional analgesic medication in rectal acetaminophen receiving group was less than that in IV group (P = 0.0001).
Conclusions:
Post-operative pain in rectal acetaminophen group was less than that in intravenous acetaminophen group, and rectal acetaminophen group demanded their first additional analgesic medication later.
doi:10.5812/aapm.13175
PMCID: PMC3961018  PMID: 24660154
Acetaminophen; Pain, Postoperative; Child, Hospitalized
20.  Effect of Gabapentin on morphine demand and pain after laparoscopic sterilization using Filshie clips. A double blind randomized clinical trial 
BMC Anesthesiology  2006;6:12.
Background
A considerable number of patients require opioids during recovery after laparoscopic sterilization. This implies nausea, dizziness and sedation and increases the number of unplanned admissions. Gabapentin has shown excellent postoperative analgesic effect in a number of recent studies with few side effects. This study was designed to test whether gabapentin given preoperatively can reduce the number of patients needing morphine in the recovery period.
Methods
80 females scheduled for laparoscopic sterilization using Filshie clips were randomized to two treatment groups (Gaba group and control group).
All patients received lornoxicam 8 mg p.o. 30 min. before the procedure. Patients in the Gaba group received gabapentin 1200 mg p.o. and patients in the control group received placebo capsules prior to the procedure. All patients were anesthetized according to a protocol, using remifentanil and propofol.
Postoperative analgesia was obtained with patient controlled infusion of morphine. Pain, nausea, dizziness and sedation were scored at 2 and 4 hours after end of anesthesia. The expenditure of morphine was the primary measure for the effect of analgesia and the number of patients demanding morphine was the primary endpoint.
Results
Three patients were excluded because of procedural errors and one because of conversion to open surgery. 38 patients completed the study in each group.
32 (84%) patients in the gabapentin group and 37 (97%) patients in the control group did require morphine in the recovery period. (p = 0,049).
There was no significant difference between mean morphine consumption, pain scores and frequency of adverse effects (nausea, dizziness, sedation and vomiting)
Conclusion
The postoperative analgesic effect of gabapentin given preoperatively was confirmed in this study. For this procedure, with pain predominantly in the immediate recovery period, and of less intensity than after major surgical procedures, the effect demonstrated is much less pronounced than in similar studies of major surgery. General use of gabapentin as analgesic for laparoscopic sterilization is not supported by this study.
Trial Registration
Current Controlled Trials ISCRTN39209275
doi:10.1186/1471-2253-6-12
PMCID: PMC1637100  PMID: 17083725
21.  A Retrospective Trial Comparing the Effects of Different Anesthetic Techniques on Phantom Pain After Lower Limb Amputation 
Background
Pain and other sensations from an amputated or absent limb, called phantom pain and phantom sensations, are well-known phenomena.
Objective
The aim of this retrospective study was to evaluate the effects of anesthetic techniques on phantom pain, phantom sensations, and stump pain after lower limb amputation.
Methods
Ninety-two patients with American Society of Anesthesiologists physical status I to III were analyzed for 1 to 24 months after lower limb amputation in this retrospective study. Patients received general, spinal, or epidural anesthesia or peripheral nerve block for their amputations. Standardized questions were used to assess phantom limb pain, phantom sensation, and stump pain postoperatively. Pain intensity was assessed on a numeric rating scale (NRS) of 0 to 10. Patients' medical histories were determined from hospital records.
Results
Patients who received epidural anesthesia and peripheral nerve block perceived significantly less pain in the week after surgery compared with patients who received general anesthesia and spinal anesthesia (NRS [SD] values, 2.68 [1.0] and 2.70 [1.0], respectively). After approximately 14 to 17 months, there was no difference in phantom limb pain, phantom sensation, or stump pain among the anesthetic techniques for amputation.
Conclusions
In patients undergoing lower limb amputation, performing epidural anesthesia or peripheral nerve block, instead of general anesthesia or spinal anesthesia, might attenuate phantom and stump pain in the first week after operation. Anesthetic technique might not have an effect on phantom limb pain, phantom sensation, or stump pain at 14 to 17 months after lower limb amputation.
doi:10.1016/j.curtheres.2011.06.001
PMCID: PMC3957153  PMID: 24648582
amputation stumps; anesthesia and analgesia; limb; phantom
22.  Comparative study between effect of pre- versus post-incisional transversus abdominis plane block on acute and chronic post-abdominal hysterectomy pain 
Background:
The prevalence of persistent chronic pain after abdominal hysterectomy is 5–32%. Our objectives were to determine the influence of transversus abdominis plane (TAP) block on the incidence of acute and chronic post-hysterectomy pain and to examine potential associations between time of block administration, either before surgical incision (preemptive) or after end of surgical procedure and its effect.
Materials and Methods:
Seventy-five patients undergoing elective total abdominal hysterectomy under general anesthesia were allocated randomly to receive TAP block either pre-incisional, or before emergence from anesthesia or sham block (just a needle puncture, control group). Pain was evaluated postoperatively at rest and movement by visual analogue scale. Peri-operative analgesic requirements, sedation, postoperative nausea and vomiting scores were recorded. Patients were questioned at three, and six months after surgery for type and severity of chronic pain.
Results:
Pain scores were significantly higher in Group II versus Group I (P<0.05), but both demonstrated significantly lower pain scores than control Group. Analgesic requirements decreased significantly in patients received TAP block (P<0.0001) with more significant decrease in the pre-incisional group. The incidence of chronic pain was significantly reduced in the pre-incisional group than others. The incidence of sedation was noted to be higher in the control group (61%) versus other groups (18% and 32% respectively), at time point 12 h postoperatively but was comparable between 12, 48 h (awake and alert). Incidence of postoperative nausea and vomiting (PONV) was reduced in patients who received TAP block (16% and 29%) in Group I and II respectively versus 66.5% in Group III. There were no complications attributed to the TAP block.
Results:
Pain scores were significantly higher in Group II versus Group I (P<0.05), but both demonstrated significantly lower pain scores than control Group. Analgesic requirements decreased significantly in patients received TAP block (P<0.0001) with more significant decrease in the pre-incisional group. The incidence of chronic pain was significantly reduced in the pre-incisional group than others. The incidence of sedation was noted to be higher in the control group (61%) versus other groups (18% and 32% respectively), at time point 12 h postoperatively but was comparable between 12, 48 h (awake and alert). Incidence of postoperative nausea and vomiting (PONV) was reduced in patients who received TAP block (16% and 29%) in Group I and II respectively versus 66.5% in Group III. There were no complications attributed to the TAP block.
Conclusions:
TAP block seems to be an acceptable choice for postoperative analgesia; pre-incisional TAP block appeared to reduce the severity of acute pain, analgesic requirements with its undesirable side-effects and incidence of chronic pain in comparison with blockade before emergence from anesthesia.
doi:10.4103/0259-1162.84199
PMCID: PMC4173367
Abdominal hysterectomy; pain; TAP block
23.  Impact of chemotherapy-associated nausea and vomiting on patients' functional status and on costs: survey of five Canadian centres. 
OBJECTIVE: To estimate the effect of chemotherapy-associated nausea and emesis on patients' functional status and on costs to the health care system, the patients and society before antagonists to the serotonin (5-hydroxytryptamine) receptor subtype 5-HT3 became available. DESIGN: A 5-day prospective survey between February and May 1991 of patients receiving chemotherapy for cancer. Data were obtained from questionnaires completed by nurses and patients. SETTING: Five Canadian cancer treatment centres in Ontario (three) and Quebec (two). PATIENTS: Outpatients and inpatients 18 years of age and older who were scheduled to receive chemotherapy with a moderate to high potential for emesis as defined by standardized criteria. Patients were excluded if they were scheduled to receive an investigational antiemetic or had received chemotherapy within the previous 7 days. Of the 128 who were eligible, 112 agreed to participate; 107 returned the completed questionnaire, but the data for 15 were excluded because the patients received multiple-day chemotherapy. MAIN OUTCOME MEASURES: The degree of nausea (on a seven-point scale) and the frequency of emesis (vomiting or retching) were recorded for each day of the survey. Functional status was assessed before and after chemotherapy by means of the Functional Living Index-Emesis (FLIE). The direct health care costs and the indirect costs (e.g., of time off work) associated with nausea and emesis were estimated from the survey responses and secondary data sources. RESULTS: On the day of chemotherapy 38 of the 92 patients (41%) experienced emesis with or without nausea, and over the 5 days of the survey 72 patients (78%) reported at least one episode of nausea or emesis. The absolute risk of either problem decreased over time, but the risk of nausea relative to emesis increased over time. The FLIE scores indicated significant worsening of functional status after chemotherapy. On the day after treatment the main impact was from emesis, particularly with regard to leisure activities, household tasks and hardship to the family. Nausea had a significantly greater impact than emesis on overall functioning. The additional direct health care cost for managing emesis was estimated to be $63 and the indirect cost $121. CONCLUSIONS: Despite prophylaxis with antiemetic drugs, nausea and emesis were significant problems in this population receiving chemotherapy. The management of emesis consumed relatively small amounts of health care resources, but there were costs outside the hospital for patients and others.
PMCID: PMC1485515  PMID: 8339175
24.  Comparison of postoperative pain and satisfaction after dacryocystorhinostomy in patients operated on under local and general anesthesia 
Summary
Background
There has been only 1 study on postoperative pain after external dacryocystorhinostomy (DCR) that compared pain between 2 groups of patients; 1 group received local anesthesia and the other received general anesthesia. To further characterize the relationship between these 2 types of anesthesia and postoperative pain, we designed a study in which a single patient received these 2 different anesthesia modalities for a short interval on 2 different sides.
Material/Methods
There were 50 participants in this study. External DCR was performed on the same participant on both sides using local anesthesia on 1 side and general anesthesia on the other. Postoperative pain was measured using the visual analogue scale (VAS), and localization and timing of pain were reported by the participants. Postoperative nausea and vomiting (PONV) were documented if present.
Results
Pain levels were significantly higher with general anesthesia 3 hours post-surgery, and 6 hours post-surgery the pain remains higher following general anesthesia but is borderline insignificant (p=0.051). However, 12 hours post-surgery, there is no significant difference in the pain level (p=0.240). There was no significant difference in the localization of pain with local and general anesthesia. Postoperative nausea is significantly more frequent after general anesthesia, and vomiting only occurs with general anesthesia. Local anesthesia was preferred by 94% of the participants (47 out of 50).
Conclusions
The vast majority of patients in our study who have undergone both GA and LA DCR would choose LA again, providing a compelling case for use of the LA technique.
doi:10.12659/MSM.882730
PMCID: PMC3560633  PMID: 22534704
dacryocystorhinostomy; anesthesia; pain; PONV
25.  Comparison of ondansetron and combination of ondansetron and dexamethasone as a prophylaxis for postoperative nausea and vomiting in adults undergoing elective laparoscopic surgery 
Background:
Laparoscopic surgeries are the second most common cause of postoperative nausea and vomiting (PONV), which would cause unexpected delay in hospital discharge. This study intends to compare the efficacy and safety of the combination of ondansetron and dexamethasone with ondansetron alone given as prophylaxis for PONV in adults undergoing elective laparoscopic surgery.
Materials and Methods:
One hundred adult patients undergoing elective laparoscopic surgeries were selected and were randomly divided into 2 groups of 50 each. Group I received 4 mg of ondansetron intravenously (i.v.), whereas Group II received ondansetron 4 mg and dexamethasone 4 mg i.v. just before induction of anesthesia. Postoperatively, the patients were assessed for episodes of nausea, vomiting, and need for rescue antiemetic at intervals of 0–2, 3, 6, 12, and 24 h. Postoperative pain scores and time for the first analgesic dose were also noted.
Results:
Results were analyzed statistically. Complete response defined as no nausea or emesis and no need for rescue antiemetic during first 24 h, was noted in 76% of patients who received ondansetron alone, while similar response was seen in 92% of patients in combination group. Rescue antiemetic requirement was less in combination group (8%) as compared with ondansetron group.
Conclusion:
Combination of ondanserton and dexamethasone is more effective in preventing post operative nausea vomiting in patients undergoing laparoscopic surgery than ondansetron alone.
doi:10.4103/0974-2700.82200
PMCID: PMC3132353  PMID: 21769200
Dexamethasone; laparoscopic surgery; ondansetron; postoperative nausea vomiting

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