drugset / Trial / NCT05017246
Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.1 % | Other |
| Subject | Lidocaine | Other / unclassified | 1 mg/kg | — |
| Subject | Morphine | Other / unclassified | 0.15 mg | Other |