Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial

Phase 4RecruitingNCT06666985

First Affiliated Hospital, Sun Yat-Sen University700 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

700

Conditions

Patients Undergoing Major Laparoscopic Abdominal Surgery

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Quality of recovery

Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)

Time frame: Postoperative day 1

Secondary Outcomes

Quality of recovery

Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)

Time frame: Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier)

Quality of life

Quality of life is measured using the European Quality of life-5 Dimensions-5 Level (EQ-5D-5L)

Time frame: 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)

Time frame: Day of surgery

Worst pain score

Worst pain score is measured using a numeric rating scale (NRS 0-10)

Time frame: 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

Time frame: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)

Patient satisfaction

Patient satisfaction is measured using a bespoke questionnaire

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: During operation and up to Postoperative day 30

Postoperative mobilisation

Postoperative mobilisation is ability to transfer from bed to chair, with or without assistance

Time frame: Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)

Doses of antiemetics administered postoperatively (number of administration)

Time frame: 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

Time frame: 1 Day after surgery

Days at Home and well After Surgery (DAH-30)

Time frame: Postoperative day 30

Mortality