Feasibility study for a randomized clinical trial of bupivacaine, lidocaine with adrenaline, or placebo wound infiltration to reduce postoperative pain after laparoscopic cholecystectomy

Abstract

Background Short‐term pain relief can be achieved by local anaesthetic infiltration of port sites at the end of laparoscopic surgery. This study aimed to assess feasibility of performing an RCT to evaluate short‐term postoperative analgesia after laparoscopic surgery in Nigeria using two local anaesthetics for port‐site infiltration versus saline placebo. Methods This was a placebo‐controlled, patient‐ and outcome assessor‐blinded, external feasibility RCT. Patients undergoing elective laparoscopic cholecystectomy for symptomatic ultrasound‐proven gallstones were randomized into three groups: lidocaine with adrenaline (epinephrine), bupivacaine or saline control. The feasibility of recruitment, compliance with randomized treatment allocation, and completion of pain and nausea outcome measures were evaluated. Pain was assessed at 2, 6, 12 and 24 h after surgery using a 0–10‐point numerical rating scale (NRS) and a four‐point verbal rating scale. Nausea was assessed using NRS at the same time points. Clinical outcomes were assessed only in patients who received the correct randomized treatment allocation. Results Of 79 patients screened for eligibility, 69 were consented and randomized (23 per group). Overall, compliance with randomized treatment allocation was achieved in 64 patients (93 per cent). All pain and nausea assessments were completed in these 64 patients. On the NRS, most patients had moderate to severe pain at 2 h (39 of 64, 61 per cent), which gradually reduced. Only six patients (9 per cent) had moderate to severe pain at 24 h. Conclusion Recruitment, compliance with the randomized allocation, and completion of pain outcome measures were satisfactory. This study demonstrates the feasibility of conducting a surgical RCT in a resource‐limited setting. Registration number: ISRCTN 17667918 (https://www.isrctn.com).