Intrathecal morphine for pain control after major laparoscopic abdominal surgery
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial
This trial will test whether adding a single intrathecal morphine injection to usual care improves early recovery and pain for adults having major laparoscopic abdominal surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06666985 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, sham-controlled Phase 4 trial compares a single-dose intrathecal morphine plus usual care versus a sham intrathecal procedure plus usual care in adults undergoing elective major laparoscopic or robotic abdominal surgery. Participants are randomized on the day of surgery and outcome assessors collect data on the day of surgery and postoperative day 1, including the 15-item Quality of Recovery (QoR-15) score. The primary goal is to detect a clinically meaningful improvement of at least 6 points on QoR-15 at postoperative day 1. Safety monitoring includes surveillance for opioid-related adverse events such as respiratory depression and hemodynamic instability.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for elective major laparoscopic or robotic abdominal surgery (colorectal, gynaecology, hepato-biliary, upper GI, or urology) with expected surgery duration ≥2 hours and anticipated hospital stay ≥24 hours who can give informed consent.
Not a fit: Patients with contraindications to intrathecal injection, coagulopathy, allergy to study drugs, cognitive impairment preventing questionnaire completion, or those likely to require postoperative invasive ventilation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding intrathecal morphine could improve early postoperative recovery and pain control while reducing systemic opioid requirements.
How similar studies have performed: Prior studies of intrathecal morphine in abdominal and other surgical settings have often shown improved analgesia and opioid-sparing effects, but high-quality sham-controlled evidence specifically in major laparoscopic surgery is limited and safety concerns like respiratory depression remain.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xia Feng
- Email: fengxia@mail.sysu.edu.cn
- Phone: 86-13688877856
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.