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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

TAP block w normal saline

Intervention Type PROCEDURE

TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)

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

Group Type EXPERIMENTAL

TAP block w Liposomal bupivacaine

Intervention Type DRUG

TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)

Interventions

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TAP block w Liposomal bupivacaine

TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)

Intervention Type DRUG

TAP block w normal saline

TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)

Intervention Type PROCEDURE

Other Intervention Names

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Exparel

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes