Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial
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 interview with outcome assessors and complete the CRFs on the day of surgery, postoperative day 1, day 2, day 3 and up to postoperative day 30
• 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)