Beilin 2008.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Israel Funding: charity |
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Participants | 82 ASA 1 to 3 patients, aged 20 to 72 years, undergoing general, gynaecological, urological or orthopaedic surgery Exclusion criteria were not fluent in Hebrew, serious hearing or visual impairment precluding neuropsychological testing, absence of consent, history of head trauma, neurological disease, alcoholism, drug abuse and consumption of psychotropic drugs or antidepressants |
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Interventions |
Treatment group: patient‐controlled lumbar (L2‐L4; catheter advanced 3 to 4 cm cephalad) epidural analgesia with 3 mL of 2% lidocaine as a test followed by 12 mL of 0.5% bupivacaine and 50 to 100 mcg of fentanyl 15 minutes before surgical incision, and bupivacaine 0.1% and fentanyl 2 mcg/mL for 24 hours (n = 30) Control group: IV patient‐controlled analgesia with morphine for 24 hours (n = 30) General anaesthesia for all participants |
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Outcomes | Pain: "Pain intensity was significantly greater in patients of the IV group throughout the observation period, both at rest and during coughing" | |
Notes | Data not extractable for abdominal surgery only. Study authors contacted 23 February 2016, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomly assigned", "by a schedule based on a random‐numbers table" |
Allocation concealment (selection bias) | Unclear risk | "Preoperative evaluation was performed by an anaesthesiologist, 3 to 7 days before surgery", "Additional
information, including age, weight, demographic status, and education, were documented for patients who consented to participate in the study", "randomized immediately prior to surgery", "by a schedule based on a random‐numbers table" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | High risk | High rate of drop‐outs: "A total of 22 patients dropped from the study because of failure to complete the second (postoperative) testing session for various reasons: A total of 6 patients did not feel well enough to cooperate; 5 were disconnected from the patient‐controlled pump early due to nausea and vomiting; and 11 had other reasons (fever, lack of optical glasses, noisy setting, refusal to participate in second testing, etc.)" |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced: "The groups were similar in demographic characteristics, including body weight, age, male‐to‐female ratio, years of education, type and duration of surgery" |