The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section

January 30, 2020 updated by: Jaimey M. Pauli, MD, Milton S. Hershey Medical Center
This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Milton S. Hershey 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

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients >18 years of age
  • Scheduled cesarean section with or without bilateral tubal ligation
  • Planned performance of a Pfannenstiel incision
  • Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center

Exclusion Criteria:

  • History of opioid use
  • History of chronic pain syndrome
  • Use of general anesthesia during cesarean delivery
  • Postoperative SICU admission
  • Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo- Tap block w normal saline
After completion of surgery with closer of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, 20cc of Normal saline will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm
Procedure: TAP block w normal saline
TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)
EXPERIMENTAL: Intervention-Tap block w Liposomal bupivacaine
After completion of surgery w closure of skin incision a TAP block will be performed. On confirmation of entering the fascial plane, Liposomal bupivacaine 0.33% (10 ml diluted to 20 ml using sterile normal saline) will be injected after negative aspiration. That will complete the intervention. 20 patients will be in this arm
Drug: TAP block w Liposomal bupivacaine
TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative narcotic use
Time Frame: initial 48 hours postoperatively
Patient use of standard postoperative narcotics (percocet) will be measured.
initial 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective pain scores using 1-10 VAS system
Time Frame: initial 48 hours postoperatively
Subjective pain scores using 1-10 VAS system will be measured
initial 48 hours postoperatively

Collaborators and Investigators

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

Sponsor

Milton S. Hershey Medical Center

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

Primary Completion (ACTUAL)

December 17, 2019

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00005133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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