Actively Recruiting
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-11-24
700
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or over and able to give informed consent
- Elective laparoscopic or robotic abdominal surgery in colorectal, gynaecology, hepato-biliary (including pancreatic), upper gastrointestinal, or urology/renal specialties
- Anticipated surgery duration of 2 hours or more
- Anticipated hospital stay of 24 hours or more after surgery
You will not qualify if you...
- Allergy to study drugs
- Anatomical factors preventing intrathecal injection
- Expected need for postoperative invasive ventilation
- American Society of Anesthesiologists (ASA) score of IV or higher
- Coagulopathies (INR >1.3 or platelet count <100x10^9/L)
- Cognitive impairment that prevents study participation
- Use of anticoagulant drugs (except aspirin) not properly paused before surgery
- Infection near the planned intrathecal injection site
- Ongoing sepsis
- Previous participation in this trial with a new abdominal surgery planned
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xia Feng
CONTACT
J
Jiangtao Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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