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

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

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