drugset / Trial / NCT05017246

Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy

NCT05017246 ↗

Phase 2 Terminated 110 enrolled Washington University School of Medicine
RandomizedParallel-groupOpen-labelSupportive care

Summary

To determine if opioid consumption postoperatively among patients undergoing non-emergent laparotomy by the gynecologic oncology service who receive intrathecal morphine with intraoperative lidocaine (IML) infusion are lower than patients who have epidural anesthesia with PCA (EPCA).

Timeline

Start
2022-01-18
Primary completion
2024-07-17
Completion
2024-08-29

Outcome

Met primary endpoint

Stopped (Enrollment): “Low accrual”

registry analysis (superiority test); Epidural Bupivacaine With Hydromorphone Patient-controlled Anesthesia (EPCA) vs Intrathecal Morphine With Intraoperative Lidocaine Infusion; p = 0.0249; NCT05017246 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.1 % Other
Subject Lidocaine Other / unclassified 1 mg/kg —
Subject Morphine Other / unclassified 0.15 mg Other