NCT05017246

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

A Randomized Trial Comparing Intrathecal Morphine and Intraoperative Lidocaine Infusion to Epidural Anesthesia With Postoperative PCA for Patients Undergoing Exploratory Laparotomy on the Gynecologic Oncology Service.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer Debulking
• Enlarged Uterus
• Fibroid Uterus
• Adnexal Mass

Interventions

Type	Name	Description
DRUG	Bupivacaine	-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
DRUG	Morphine	-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
DRUG	Lidocaine	-Lidocaine infusion 1 mg/kg ideal body weight (IBW)

Timeline

• Start date: 2022-01-18
• Primary completion: 2024-07-17
• Completion: 2024-08-29
• First posted: 2021-08-23
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study