Patients Undergoing Major Laparoscopic Abdominal Surgery
Conditions
Keywords
laparoscopic surgery, intrathecal morphine, quality of recovery
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
Interventions
DRUGITM + Usual Care
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.
DRUGSham ITM + Usual Care
The sham ITM mimics the ITM procedure, but the dura is not breached.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery | Postoperative day 1 | Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
CONTACTXia Feng
CONTACTJiangtao Zhou
Outcome results
None listed