Intrathecal morphine for postoperative analgesia in major laparoscopic abdominal surgery (IMPACT-Scope): a protocol for a randomised controlled trial
Abstract
Introduction: Effective perioperative pain management is a cornerstone of Enhanced Recovery After Surgery, yet standard opioid-based intravenous patient-controlled analgesia often leads to insufficient pain control, excessive adverse reactions and delayed recovery following laparoscopic abdominal surgery. Intrathecal morphine (ITM) has shown promising analgesic efficacy in abdominal and obstetric procedures but high-quality evidence supporting its use in major laparoscopic surgery remains limited. The ITM for postoperative analgesia in major laparoscopic abdominal surgery (IMPACT-Scope) trial aims to determine whether ITM, when added to usual care, improves postoperative recovery quality compared with usual care alone.
Method and analysis: This is a multicentre, parallel-group, two-arm, randomised, sham-controlled, double-blind, superiority trial with an integrated full health economic evaluation. A total of 700 adult patients undergoing elective major laparoscopic or robotic abdominal surgery at 15 tertiary teaching hospitals in South and Central China will be enrolled. Participants are randomised (1:1) to assign either ITM (300 µg of preservative-free morphine) or sham ITM plus usual care. The primary outcome is the quality of recovery at postoperative day (POD) 1, measured by the 15-item Quality of Recovery questionnaire (QoR-15). Secondary outcomes include QoR-15 at POD 2 and POD 3, opioid consumption, postoperative mobilisation, adverse events and length of stay. Health…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 700 participants or records.
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