Clinical trial NCT06666985: Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
Official title: Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Patients Undergoing Major Laparoscopic Abdominal Surgery
Keywords: laparoscopic surgery
intrathecal morphine
quality of recovery
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Quality of recovery
timeFrame: Postoperative day 2 , Postoperative day 3 (or at discharge, if earlier)
measure: Quality of life
timeFrame: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier) and Postoperative day 30
measure: Pain scores in the post-anaesthesia recovery unit
timeFrame: Day of surgery
measure: Worst pain score
timeFrame: Postoperative day 1, Postoperative day 2, and Postoperative day 3 (or at discharge, if earlier)
measure: Anaesthesia-related discomfort (nausea and/or vomiting, drowsiness, shivering, pruritus)
timeFrame: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
measure: Patient satisfaction
timeFrame: Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
measure: Time in minutes to tracheal extubation from the end of anaesthesia
timeFrame: 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
measure: Number of pain management visits
timeFrame: Postoperative day 1, Postoperative day 2, Postoperative day 3(or at discharge, if earlier), day of discharge and Postoperative day 30
measure: Postoperative pulmonary complications
timeFrame: Postoperative day 1, Postoperative day 2 and Postoperative day 3 (or at discharge, if earlier)
measure: Respiratory depression
timeFrame: Day of surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
measure: Total opioid consumption
timeFrame: During operation and up to Postoperative day 30
measure: Postoperative mobilisation
timeFrame: Postoperative day 1,Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
measure: Doses of antiemetics administered postoperatively (number of administration)
timeFrame: Day of Surgery, Postoperative day 1, Postoperative day 2, Postoperative day 3 (or at discharge, if earlier)
measure: Length of Hospital Stay
timeFrame: 1 Day after surgery
measure: Days at Home and well After Surgery (DAH-30)
timeFrame: Postoperative day 30
measure: Mortality
timeFrame: Postoperative day 30
Other outcomes:
Locations:
Study officials:
References: