Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial
NCT ID: NCT06666985
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
700 participants
INTERVENTIONAL
2024-12-16
2026-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Sham ITM + Usual Care
The sham ITM mimics the ITM procedure, but the dura is not breached.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Feng Xia
Professor
Locations
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2023-989
Identifier Type: -
Identifier Source: org_study_id
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