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

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

June 1, 2026

Study Completion Date

December 31, 2026

Conditions
Patients Undergoing Major Laparoscopic Abdominal Surgery
Interventions
DRUG

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.

DRUG

Sham ITM + Usual Care

The sham ITM mimics the ITM procedure, but the dura is not breached.

All Listed Sponsors
lead

First Affiliated Hospital, Sun Yat-Sen University

OTHER

NCT06666985 - Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial | Biotech Hunter | Biotech Hunter