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

  • Sofie Glazemakers*
  • , Stijn H. J. Ketelaers
  • , Harm J. Scholten
  • , Robert-Jan Schipper
  • , Michael I. Meesters
  • , Jacobus W. A. Burger
  • , Johanne G. Bloemen
  • *Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.
Original languageEnglish
Article numbere0340859
Number of pages10
JournalPLOS ONE
Volume21
Issue number1
DOIs
Publication statusPublished - 21 Jan 2026

Keywords

  • POSTOPERATIVE PAIN MANAGEMENT
  • ENHANCED RECOVERY
  • DOUBLE-BLIND
  • INTRAVENOUS LIDOCAINE
  • EPIDURAL ANALGESIA
  • LOCAL-ANESTHETICS
  • INFUSION
  • QUALITY
  • SCORE
  • EFFICACY

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