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

NCT06666985 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Phase

Phase 4

Started

2024-12-16

Last updated

2026-08-28

Condition(s) studied

Patients Undergoing Major Laparoscopic Abdominal Surgery

Investigational drug(s) / intervention(s)

ITM + Usual CareSham ITM + Usual Care

ITM + 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.

Sham ITM + Usual Care: The sham ITM mimics the ITM procedure, but the dura is not breached.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Quality of recovery — Postoperative day 1
Quality of recovery is measured using the 15-item Quality of Recovery Questionnaire (QoR-15)

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

More First Affiliated Hospital, Sun Yat-Sen University trials in China

Tissue-engineered Skin Graft Repair of Autologous Scar Dermal Scaffolds Recruiting

Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD Starting soon

Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy Recruiting

Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients Recruiting

AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06666985 on ClinicalTrials.gov ↗ ← All trials in China