A randomised trial validating the efficacy of standardised pain management regimen developed through a quality improvement study in laparoscopic surgery

Abstract Background: Post-operative pain mainly determines patient satisfaction but largely remains unaddressed owing to a lack of a uniform standardised perioperative pain management regimen, despite several existing recommendations on multimodal analgesic regimens. Patients and Methods: This study included patients undergoing laparoscopic cholecystectomy or inguinal hernia repair between 31 May 2019 and 31 December 2021. Phase 1 comprised an observational study for assessment of baseline post-operative pain and a root cause analysis for development of a standardised pain management regimen, followed by Plan-Do-Study-Act (PDSA) cycle(s) until the aim was achieved, i.e. post-operative pain scores on Visual Analogue Scale (VAS) ≤3 at 0 h, 1 h, 2 h, 4 h, 6 h, 12 h, at discharge, 1 week, 6 weeks and 3 months, in at least 70% of patients. Phase 2 included a randomised trial to test the standardised pain management regimen. Results: In Phase 1 ( n = 20), suboptimal pain control was noted till 6 h postoperatively in the majority. The first PDSA cycle ( n = 20) achieved the aim of the quality improvement (QI) study, and the regimen was standardised. Interim analysis revealed significantly lower median pain scores ( P < 0.05) at all-time intervals. In Phase 2, sixty patients were randomised, 30 in each arm. The number of patients with acceptable pain (VAS ≤3) at 1 h was significantly ( P = 0.038) higher in the QI arm, correlating with significantly lower median pain scores ( P = 0.01). However, pain scores at other intervals were comparable. Conclusion: A standardised pain management regimen may significantly benefit early post-operative pain following laparoscopic surgery.