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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITM + Usual Care | Experimental |
| |
| Sham ITM + Usual Care | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITM + Usual Care | Drug | The participants allocated to this group will receive ITM (Intrathecal Morphine) in addition to usual care with opioid-based PCA(Patient-Controlled Analgesia). ITM consists of an intrathecal injection of 300 micrograms (0.3mg) of preservative-free morphine.Usual care involves postoperative analgesia with opioid-based PCA without postoperative continuous infusion of opioids. No other drugs other than opioids are allowed in the PCA. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery | Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15) | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery | Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15) | Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier) |
| Quality of life |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Feng | Contact | 86-13688877856 | fengxia@mail.sysu.edu.cn | |
| Jiangtao Zhou | Contact | impact_scope@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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|
| Sham ITM + Usual Care | Drug | The sham ITM mimics the ITM procedure, but the dura is not breached. |
|
Quality of life is measured using the European Quality of life-5 Dimensions-5 Level (EQ-5D-5L)
| 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 | Pain scores is measured using a numeric rating scale (NRS 0-10) | Day of surgery |
| Worst pain score | Worst pain score is measured using a numeric rating scale (NRS 0-10) | 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) | Anaesthesia-related discomfort is measured using a bespoke questionnaire | Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) |
| Patient satisfaction | Patient satisfaction is measured using a bespoke questionnaire | 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 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 | Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier) |
| Respiratory depression | Respiratory depression is defined as respiratory rate less than 8 breaths per minute AND need for medical intervention | Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) |
| Total opioid consumption | Total opioid consumption is transformed into oral morphine equivalent daily dose | During operation and up to Postoperative day 30 |
| Postoperative mobilisation | Postoperative mobilisation is ability to transfer from bed to chair, with or without assistance | 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 | 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 | 1 Day after surgery |
| Days at Home and well After Surgery (DAH-30) | Postoperative day 30 |
| Mortality | Postoperative day 30 |
| ID | Term |
|---|---|
| C111653 | SLC22A18 protein, human |
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