Katz 2003.
| Methods | RCT Approval was obtained from the research ethics board. All patients gave written informed consent to participate before enrolling in the study Setting: Canada Funding: governmental |
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| Participants | Patients with American Society of Anesthesiologists (ASA) physical status 1 to 3, age between 19 and 75 years, weight between 45 and 90 kg, height between 150 and 175 cm, body mass index ≤ 30, able to speak and read English, scheduled for major gynaecological surgical procedures by laparotomy (horizontal or midline incision) | |
| Interventions |
Treatment groups: LEA (L2‐L3 or L3‐L4 with the catheter advanced 3 to 4 cm past the tip of the needle) with lidocaine 2%, epinephrine 5 mcg/mL and fentanyl 4 mcg/kg before (n = 45) or after (n = 49) the incision Control group: sham epidural procedure (n = 47). This group was split in half for comparison with each subgroup General anaesthesia and IV PCA with morphine for 48 hours for all participants |
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| Outcomes | VAS scores at rest at 6, 24 and 48 hours VAS scores on movement at 24 and 48 hours |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A randomization schedule was computer‐generated by a biostatistician (not otherwise involved in the study) and was provided to the hospital pharmacist, who prepared and dispensed drugs for clinical trials. The randomization schedule specified the group (1, 2 or 3) to which each prospective participant would be allocated upon enrolment in the trial |
| Allocation concealment (selection bias) | Low risk | An opaque envelope containing participant number and group assignment was prepared, sealed and numbered for each participant by the hospital pharmacist |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | A standard volume of lidocaine, fentanyl and preservative‐free saline for epidural and intravenous administration was prepared in separate syringes, coded for blinding purposes, numbered and dispensed by the hospital pharmacy on the day of surgery. The pharmacist who dispensed study medications was not involved in any other aspect of the study. The anaesthesiologist in charge of the case was aware of group allocation for control group participants and was not involved in postoperative management or data collection. Sham epidural catheter: "The anaesthesiologist went through all the motions of placing an epidural catheter, including prepping and cleansing the skin, infiltrating the skin and interspinous regions with 2–3 ml lidocaine (2%), applying pressure as if inserting the needle, simulating loss of resistance, and threading of the catheter. The epidural needle was removed, and the exposed length of catheter was wrapped in gauze and taped to the patient’s back. A test dose of 3–5 ml normal saline was injected into the catheter that drained into the gauze" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All participants and personnel involved in participant management and data collection were unaware of the group to which the participant had been allocated. The anaesthesiologist in charge of the case was aware of group allocation for control group participants and was not involved in postoperative management or data collection |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 11 withdrawn from the analysis ‐ 5 could not have the epidural catheter placed. In addition, 7 participants were withdrawn during surgery owing to intraoperative protocol violations, and 4 were withdrawn after surgery owing to apnoea and chest wall rigidity upon extubation requiring reintubation, faulty PCA equipment and nausea and back pain |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups well balanced, except larger number of participants with pain history in the post‐incisional group Not in intention‐to‐treat |