Intraoperative TAP Block After Repeat Cesarean

November 12, 2024 updated by: Gianna Wilkie, University of Massachusetts, Worcester

Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery

The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
  • Pregnancy and delivery care obtained at UMass Memorial Medical Center
  • Patients able to provide written informed consent
  • English, Spanish, or Portuguese-speaking patients

Exclusion Criteria:

  • Participants who are under the age of 18 years
  • Active labor.
  • Baseline pain score > 6.
  • Unable to provide informed consent.
  • Prisoners will be excluded from this research.
  • Narcotic use in the 2 weeks prior to delivery.
  • Active substance abuse.
  • Inability to take narcotic analgesia.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP Block Group
Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery.
Procedure: TAP Block Group
Participants will receive a surgeon administered TAP block.
No Intervention: Standard of Care Postoperative Pain Control
Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Narcotic Use in Morphine Equivalents
Time Frame: From time of surgery through postpartum day 4
Daily Narcotic Use in Morphine Equivalents
From time of surgery through postpartum day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first administered narcotic (oral or parental)
Time Frame: From time of surgery through postpartum day 4
Time to first administered narcotic (oral or parental) post cesarean delivery
From time of surgery through postpartum day 4
Daily Average Pain Score
Time Frame: From time of surgery through postpartum day 4
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
From time of surgery through postpartum day 4
Daily Maximum Pain Score
Time Frame: From time of surgery through postpartum day 4
Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain
From time of surgery through postpartum day 4
Time to First Ambulation
Time Frame: From time of surgery through postpartum day 4
Time to First Ambulation post cesarean delivery
From time of surgery through postpartum day 4
Time to First Solid Food
Time Frame: From time of surgery through postpartum day 4
Time to First Solid Food
From time of surgery through postpartum day 4

Collaborators and Investigators

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

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Gianna Wilkie, MD, University of Massachusetts Chan Medical School

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.

General Publications

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000407

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

No

Studies a U.S. FDA-regulated device product

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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