Rectus Sheath Block for Analgesia After Gynecological Laparotomy

January 29, 2026 updated by: Duke University

Rectus Sheath Block With Liposomal Bupivacaine for Postoperative Analgesia Following Gynecologic Oncology Surgery: A Pilot Study

Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.

Study Overview

Status

Status

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

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.
90

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 4

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.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients ≥18 years presenting for a laparotomy for Gynecologic malignancy with a vertical incision.
  2. ASA Classification II or III.
  3. English speaking patients

Exclusion Criteria:

  1. BMI >50 kg/m2.
  2. Chronic pain or chronic opioid therapy.
  3. Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen (NSAIDs and acetaminophen)

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: Prevention
  • Allocation: Non-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.
Experimental: Rectus Sheath Block Group (Prospective arm)
Thirty subjects will be prospectively enrolled and will receive a bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side.
Procedure: Rectus sheath block
bilateral rectus sheath block under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side deposited between the rectus abdomens muscle and the posterior rectus sheath.
Drug: Liposomal bupivacaine
133 mg liposomal bupivacaine per side for rectus sheath block
Drug: Bupivacaine Hydrochloride
20 mL bupivacaine 0.25% per side for rectus sheath block
Active Comparator: Thoracic Epidural Analgesia Group (retrospective arm)
60 patients who received thoracic epidural analgesia as part of our enhanced recovery after surgery protocol and stayed in hospital for at least 72 h.
Procedure: Thoracic Epidural Analgesia
Low thoracic Epidural Analgesia.
Drug: Bupivacaine-Hydromorphone Cassette
Bupivacaine 0.625% with hydromorphone 10 mcg/ml for the epidural solution

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
Postoperative opioid consumption 0- 72 hours after surgery
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)

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
Total postsurgical opioid consumption at 0-24, 24-48, and 48-72 hours
Time Frame: 0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)
0-24 hours, 24-48 hours and 48-72 hours after time 0 (end of surgery)
Number of patients with intraoperative hypotension
Time Frame: Intraoperative
Intraoperative
Number of patients with postoperative hypotension
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antiemetics
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Number of patients receiving rescue antipruritics
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Number of patients developing ileus or constipation
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Number of patients with respiratory Depression
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores through 72 hours (AUC0-72)
Time Frame: 0-72 hours after time 0 (end of surgery)
Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
0-72 hours after time 0 (end of surgery)
Maximum pain scores reported
Time Frame: 0-72 hours after time 0 (end of surgery)
Visual analog scores 0-10 (0=no pain, 10=worst possible pain)
0-72 hours after time 0 (end of surgery)
Time to mobilization
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Time to urinary catheter removal
Time Frame: 0-72 hours after time 0 (end of surgery)
0-72 hours after time 0 (end of surgery)
Duration of post anesthesia care unit (PACU) stay
Time Frame: 0-6 hours after time 0 (end of surgery)
0-6 hours after time 0 (end of surgery)
Duration of hospital stay
Time Frame: 0-10 days after surgery
0-10 days after surgery
Number of patients receiving intraoperative vasopressors
Time Frame: Intraoperative
Intraoperative

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications related to rectus sheath block or epidural analgesia
Time Frame: 0-72 hours after time 0 (end of surgery)
Inadvertent dural puncture, postdural puncture headache, need to discontinue epidural due to hypotension, epidural hematoma.
0-72 hours after time 0 (end of surgery)

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.
Duke University

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: Ashraf Habib, M.D., Duke University

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.
October 10, 2024

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.
November 28, 2025

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.
November 28, 2025

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 22, 2024

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 27, 2024

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 28, 2024

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.
February 2, 2026

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.
January 29, 2026

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.
January 1, 2026

More Information

Terms related to this study

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.
  • Pro00115981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared upon reasonable request

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.

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings