Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Quality of recovery
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ITM + Usual Care
Intervention: ITM + Usual Care (Drug)
Sham ITM + Usual Care
Intervention: Sham ITM + Usual Care (Drug)
Outcomes
Primary Outcomes
Quality of recovery
Time Frame: Postoperative day 1
Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
Secondary Outcomes
- Quality of recovery(Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier))
- Quality of life(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) and Postoperative day 30)
- Pain scores in the post-anaesthesia recovery unit(Day of surgery)
- Worst pain score(Postoperative day 1, Postoperative day 2, and Postoperative day 3 (or at discharge, if earlier))
- Anaesthesia-related discomfort (nausea and/or vomiting, drowsiness, shivering, pruritus)(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Patient satisfaction(Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Time in minutes to tracheal extubation from the end of anaesthesia(From end of anesthesia to tracheal extubation on day of surgery or from end of anesthesia to discharge day (for ICU patients) up to 48 hours)
- Number of pain management visits(Postoperative day 1, Postoperative day 2, Postoperative day 3(or at discharge, if earlier), day of discharge and Postoperative day 30)
- Postoperative pulmonary complications(Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier))
- Respiratory depression(Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Total opioid consumption(During operation and up to Postoperative day 30)
- Postoperative mobilisation(Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Doses of antiemetics administered postoperatively (number of administration)(Day of Surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier))
- Length of Hospital Stay(1 Day after surgery)
- Days at Home and well After Surgery (DAH-30)(Postoperative day 30)
- Mortality(Postoperative day 30)
Investigators
Feng Xia
Professor
First Affiliated Hospital, Sun Yat-Sen University