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

NCT ID: NCT05017246

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2024-08-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Epidural bupivacaine with hydromorphone patient-controlled anesthesia (EPCA)

• 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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Intrathecal morphine with intraoperative lidocaine infusion

• 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

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

Other Intervention Names

Duramorph

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Premal H Thaker, M.D., MS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

202105007

Identifier Type: -

Identifier Source: org_study_id