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NCT06666985: IMPACT-Scope

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

Recruiting now Phase 4 Last updated 24 November 2025
What this trial tests

Phase 4 trial testing ITM + Usual Care in Patients Undergoing Major Laparoscopic Abdominal Surgery in 700 participants. Currently enrolling.

Timeline
16 December 2024
Primary endpoint
1 June 2026
31 December 2026

Quick facts

Lead sponsorFirst Affiliated Hospital, Sun Yat-Sen University
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment700
Start date16 December 2024
Primary completion1 June 2026
Estimated completion31 December 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Who can join

18 and older, any sex, with Patients Undergoing Major Laparoscopic Abdominal Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06666985.

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