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

Sun Yat-sen University

Status and phase

Enrolling

Phase 4

Conditions

Patients Undergoing Major Laparoscopic Abdominal Surgery

Treatments

Drug: Sham ITM + Usual Care

Drug: ITM + Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT06666985

IIT-2023-989

Details and patient eligibility

About

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

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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