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

July 14, 2025 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Premal H Thaker, M.D., MS
  • Phone Number: 314-747-3604
  • Email: thakerp@wustl.edu

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Morphine Milligram Equivalent (MME) in the Postoperative Hospital Course
Time Frame: Postoperatively while patient is in hospital (estimated to be 4 days)
Postoperatively while patient is in hospital (estimated to be 4 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Postoperative Ileus
Time Frame: Postoperatively while patient is in hospital (estimated to be 4 days)
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
Time Frame: Estimated to be 4 days
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
Time Frame: Up to 48 hours after surgery
-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
Time Frame: Day of hospital discharge (estimated to be day 4)
-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
Time Frame: Preoperative, each post-operative day while inpatient, 2 week follow-up, and 6 week follow-up
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
Time Frame: Through day 30
Through day 30
Rate of Deep Vein Thrombosis (DVT) or Pulmonary Thromboembolism (PTE)
Time Frame: From day of surgery (day 1) to 6 weeks after surgery
From day of surgery (day 1) to 6 weeks after surgery
Rate of Persistent Pain
Time Frame: At 6 week follow-up
-As determined by an NRS pain score ≥ 5
At 6 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Premal H Thaker, M.D., MS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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