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

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.