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NCT06666985: IMPACT-Scope
Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
Phase 4 trial testing ITM + Usual Care in Patients Undergoing Major Laparoscopic Abdominal Surgery in 700 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | First Affiliated Hospital, Sun Yat-Sen University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 700 |
| Start date | 16 December 2024 |
| Primary completion | 1 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- ITM + Usual Care — full drug profile →
- Sham ITM + Usual Care — full drug profile →
Conditions studied
- Patients Undergoing Major Laparoscopic Abdominal Surgery — all drugs for Patients Undergoing Major Laparoscopic Abdominal Surgery →
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.
Verify or expand the search:
- PubMed search for NCT06666985
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06666985 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital, Sun Yat-Sen University
- Last refreshed: 24 November 2025
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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