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.

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).

Study Overview

• Status: Terminated
• Conditions: Fibroid Uterus; Adnexal Mass; Cancer Debulking; Enlarged Uterus
• Intervention / Treatment: Drug: Bupivacaine; Drug: Morphine; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Bupivacaine; -Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
Experimental: 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	Drug: Morphine; -Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution); Other Names: Duramorph; Drug: Lidocaine; -Lidocaine infusion 1 mg/kg ideal body weight (IBW)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course	Postoperatively while patient is in hospital (estimated to be 4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Postoperative Ileus	Defined by bilious emesis requiring a change in diet to nothing-per-mouth (NPO) status or nasogastric tube placement (NGT) in the absence of other indications. Patients who had NGT placed prophylactically at the time of surgery were not considered to have an ileus unless an NGT was reinserted or they met the above criteria. Participants will be assigned a value of yes ileus or no ileus. The rate of post op ileus is defined as the observed number of yes ileus in each study arm divided by the total number of subjects in the study arm.	Postoperatively while patient is in hospital (estimated to be 4 days)
Length of Hospital Stay	Length of stay will be determined by the dates of admission as recorded in EPIC (days).	Estimated to be 4 days
Rate of Postoperative Hypotension	-Postoperative hypotension will be defined as <90/50 (as previously defined by Huepenbecker, et al.) or a 20% decrease from the preoperative office visit.	Up to 48 hours after surgery
Patient Satisfaction With Pain Control	-Patients will be asked on day of discharge if they were satisfied with their pain control during their hospitalization. They will be able to choose from the following: 0=satisfied, 1= somewhat satisfied, 2= neutral, 3=somewhat dissatisfied, 4=dissatisfied).	Day of hospital discharge (estimated to be day 4)
Change in Pain Scores	Pain scores will be determined by the 0-10 numeric rating scale (NRS). 0=no pain and 10=the most pain. A higher score indicates more pain.	Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
30 Day Readmission Rate		Through day 30
Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)		From day of surgery (day 1) to 6 weeks after surgery
Rate of Persistent Pain	-As determined by an NRS pain score ≥ 5	At 6 week follow-up

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Premal H Thaker, M.D., MS, Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): August 29, 2024

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Epidural; ERAS; Opioid consumption; Ileus; Intrathecal; Multi-modal anesthesia
• Additional Relevant MeSH Terms: Neoplasms; Connective Tissue Diseases; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Bupivacaine; Morphine; Lidocaine
• Other Study ID Numbers: 202105007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No