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

NCT05017246 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 202105007
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ERAS; Multi-modal anesthesia; Opioid consumption; Intrathecal; Epidural; Ileus

Outcome Measures

Primary Outcomes (1)

• Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course

  Postoperatively while patient is in hospital (estimated to be 4 days)

Secondary Outcomes (8)

• Rate of Postoperative Ileus

  Postoperatively while patient is in hospital (estimated to be 4 days)

• Length of Hospital Stay

  Estimated to be 4 days

• Rate of Postoperative Hypotension

  Up to 48 hours after surgery

• Patient Satisfaction With Pain Control

  Day of hospital discharge (estimated to be day 4)

• Change in Pain Scores

  Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up

Study Arms (2)

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)

ACTIVE COMPARATOR

* Standard of care at Washington University School of Medicine/Barnes-Jewish Hospital * Day of surgery: preoperative tylenol, gabapentin, celebrex, and epidural dosing per standard protocol. * Intraoperative: dexamethasone and epidural bupivacaine * Day of surgery postoperative: hydromorphone PCA, toradol, ibuprofen, tylenol, epidural bupivacaine * Postoperative: hydromorphone PCA, ibuprofen, oxycodone

Drug: Bupivacaine

Intrathecal morphine with intraoperative lidocaine infusion

EXPERIMENTAL

* Day of surgery: tylenol, gabapentin, celebrex, and preoperative intrathecal morphine one time injection (150mcg) * Intraoperative: dexamethasone and lidocaine infusion 1 mg/kg ideal body weight * Day of surgery postoperative: toradol, ibuprofen, tylenol * Postoperative: ibuprofen, oxycodone, and hydromorphone prn

Drug: Morphine; Drug: Lidocaine

Interventions

Bupivacaine DRUG

-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)

Morphine DRUG

-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)

Also known as: Duramorph

Intrathecal morphine with intraoperative lidocaine infusion

Lidocaine DRUG

-Lidocaine infusion 1 mg/kg ideal body weight (IBW)

Intrathecal morphine with intraoperative lidocaine infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients ≥18 years old
• Undergoing non-emergent exploratory laparotomy with the Gynecologic Oncology service
• No clinical or laboratory evidence of end organ failure:
• If available:
• Platelets \> 100 K/cumm
• Hemoglobin \> 8.0 g/dl
• Serum creatinine \<1.5 mg/dl
• Creatine clearance (CrCl) ≥30 based on the original Cockcroft-Gault formula adjusted for weight.
• INR \<1.3 reference range
• All other lab values obtained as part of general preoperative work-up must be ≤1.5x normal laboratory value.

You may not qualify if:

• Patients not giving consent to participate in the study
• Unable to complete self-report pain questionnaire
• Moderate to severe kidney or liver failure per lab criteria as outlined
• Inability to hold anticoagulant medications for a safe amount of time per current ASRA guidelines
• Contraindication to lumbar puncture or epidural placement, per acute pain management service such as known coagulopathy or history of clotting disorders, history of scoliosis or lumbar fusion, infection at site of entry, or current systemic infection
• Complete bowel obstruction
• Contraindication to intravenous lidocaine
• No known pregnancy and not lactating.
• Currently septic
• Patient currently taking more than 30 MME a day preoperatively (for \>30 days)
• BMI \>50kg/m2
• Intolerance/contraindication or allergy to receiving non-steroidal anti-inflammatory drugs or acetaminophen or any other medications in the pre-operative order set

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Leiomyoma; Ileus

Interventions

Bupivacaine; Morphine; Lidocaine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides

Results Point of Contact

• Title: Dr. Premal H Thaker
• Organization: Washington University School of Medicine

thakerp@wustl.edu

314-747-3604

Study Officials

• Premal H Thaker, M.D., MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: January 18, 2022
• Primary Completion: July 17, 2024
• Study Completion: August 29, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)