Continuous wound infiltration versus placebo following elective minimally invasive colorectal surgery (CIMICS): study protocol for a randomised controlled trial

择期微创结直肠手术后持续伤口浸润与安慰剂对比研究(CIMICS):一项随机对照试验的研究方案

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Abstract

BACKGROUND: Enhanced Recovery After Surgery (ERAS) programs emphasize multimodal analgesia to minimize opioid use and improve patient outcomes. Continuous wound infiltration (CWI) with local analgesic is a promising adjunct to multimodal analgesia. However, its benefits in minimally invasive procedures and ERAS-adherent care remain unknown. This trial investigates whether the addition of CWI to standard ERAS care improves postoperative recovery following minimally invasive colorectal surgery. METHODS: In this single-centre, blinded, randomised controlled trial, 192 eligible patients are randomised to receive either a CWI system with bupivacaine 0.125% (the interventional arm), or a placebo CWI with physiological saline (the control arm). All patients receive standardized ERAS perioperative care with multimodal analgesia. The primary outcome is the Quality of Recovery-15 score (QoR-15NL) on postoperative day 2. Secondary outcomes include QoR-15NL and pain scores (postoperative days 1-5), opioid consumption, length of hospital stay, key functional recovery milestones, and 90-day postoperative complications. DISCUSSION: This will be the first randomised controlled trial evaluating the effect of CWI within minimally invasive and ERAS-adherent colorectal surgery. The trial findings may improve evidence-based perioperative care guidelines and enhance postoperative multimodal analgesia.

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