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

## TL;DR

This trial tests if continuous wound infiltration with bupivacaine improves recovery after minimally invasive colorectal surgery compared to placebo.

## Contribution

This is the first randomized controlled trial to evaluate continuous wound infiltration in ERAS-adherent minimally invasive colorectal surgery.

## Key findings

- The trial will assess the impact of CWI on postoperative recovery using the QoR-15 score.
- Results may influence evidence-based guidelines for multimodal analgesia in colorectal surgery.
- The study will provide data on opioid consumption and hospital stay duration.

## Abstract

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.

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.

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.