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Clinical Trials/NCT02847013
NCT02847013
Withdrawn
Phase 2

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

Milton S. Hershey Medical Center1 site in 1 countryJuly 27, 2016

Overview

Phase
Phase 2
Intervention
TAP block w Liposomal bupivacaine
Conditions
Pain
Sponsor
Milton S. Hershey Medical Center
Locations
1
Primary Endpoint
Postoperative narcotic use
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2016
End Date
December 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jaimey M. Pauli, MD

OB/GYN Resident

Milton S. Hershey Medical Center

Eligibility Criteria

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)

Arms & Interventions

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

Intervention: TAP block w Liposomal bupivacaine

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

Intervention: TAP block w normal saline

Outcomes

Primary Outcomes

Postoperative narcotic use

Time Frame: initial 48 hours postoperatively

Patient use of standard postoperative narcotics (percocet) will be measured.

Secondary Outcomes

  • Subjective pain scores using 1-10 VAS system(initial 48 hours postoperatively)

Study Sites (1)

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