Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
- Conditions
- Patients Undergoing Major Laparoscopic Abdominal Surgery
- Interventions
- Drug: ITM + Usual CareDrug: Sham ITM + Usual Care
- Registration Number
- NCT06666985
- Lead Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ITM + Usual Care ITM + Usual Care - Sham ITM + Usual Care Sham ITM + Usual Care -
- Primary Outcome Measures
Name Time Method Quality of recovery Postoperative day 1 Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
- Secondary Outcome Measures
Name Time Method Quality of recovery Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier) Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)
Quality of life Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) and Postoperative day 30 Quality of life is measured using the European Quality of life-5 Dimensions-5 Level (EQ-5D-5L)
Pain scores in the post-anaesthesia recovery unit Day of surgery Pain scores is measured using a numeric rating scale (NRS 0-10)
Worst pain score Postoperative day 1, Postoperative day 2, and Postoperative day 3 (or at discharge, if earlier) Worst pain score is measured using a numeric rating scale (NRS 0-10)
Anaesthesia-related discomfort (nausea and/or vomiting, drowsiness, shivering, pruritus) Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) Anaesthesia-related discomfort is measured using a bespoke questionnaire
Patient satisfaction Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) Patient satisfaction is measured using a bespoke questionnaire
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) Postoperative pulmonary complications is measured according to the Standardized Endpoints for Perioperative Medicine and the Core Outcome Measures in Perioperative and Anaesthetic Care (StEP-COMPAQ) definition
Respiratory depression Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) Respiratory depression is defined as respiratory rate less than 8 breaths per minute AND need for medical intervention
Total opioid consumption During operation and up to Postoperative day 30 Total opioid consumption is transformed into oral morphine equivalent daily dose
Postoperative mobilisation Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) Postoperative mobilisation is ability to transfer from bed to chair, with or without assistance
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 Length of Hospital Stay (in days) is number of days from starting day of surgery to the day of discharge, calculated as discharge date - surgery date + 1 day
Days at Home and well After Surgery (DAH-30) Postoperative day 30 Mortality Postoperative day 30