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

NCT05017246 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-07-31

Study results available
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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

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)

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Premal H Thaker, M.D., MS · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-18
Primary Completion
2024-07-17
Completion
2024-08-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05017246 on ClinicalTrials.gov