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Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial

RecruitingPhase 4Ages 18 Years - anyAllFirst Affiliated Hospital, Sun Yat-Sen University
NCT06666985 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn the clinical and cost effectiveness of intrathecal morphine (ITM) in addition to usual care as a postoperative pain relief strategy following major laparoscopic abdominal surgery compared with current usual care. The main questions it aims to answer are: An enhanced analgesic technique, consisting of ITM in addition to usual care , improves the postoperative quality of recovery at day 1 after surgery by at least 6 points on the 15-item quality of recovery questionnaire (QoR-15) compared to usual care alone, in patients undergoing major laparoscopic abdominal surgery? Researchers will compare ITM + Usual care to Sham ITM + Usual Care (The sham ITM mimics the ITM procedure, but the dura is not breached) to see if ITM works to postoperative pain relief. Participants will: Receive ITM + Usual care or Sham ITM + Usual care on surgery day Have in

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📋 Eligibility rules (as published)
Inclusion criteria: * Age 18 years or over AND able to give informed consent (with interpreters provided where necessary) * Elective (i.e., planned) laparoscopic or robotic abdominal surgery within one or more of the following specialties: * Colorectal * Gynaecology * Hepato-biliary (including pancreatic surgery) * Upper gastrointestinal * Urology/Renal * Anticipated duration of surgery ≥ 2 hours (from knife-to-skin to end of wound closure) * Anticipated hospital stay ≥ 24 hours (from the end of surgery) Exclusion criteria: * Allergy to study drugs * Anatomical factors making intrathecal injection impossible * Anticipated requirement for postoperative invasive ventilation * American Society of Anesthesiologists (ASA) Score \<IV * Coagulopathies (i.e. INR\>1.3 and/or platelet count\<100×10\^9/L) * Cognitive impairment leading to inability to complete the study processes and questionnaires * Drugs affecting coagulation (except aspirin), which have not been suitably and timely paused preoperatively * Infection near the planned site of intrathecal injection * Ongoing sepsis * Patients previously included in the trial and who need to return to theatre for a new abdominal surgery * Pregnancy or breast feeding
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What it tests

  • ITM + Usual Care
  • Sham ITM + Usual Care
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Where

1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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