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

Phase 2

Withdrawn

• Conditions: Pain
• Interventions: Procedure: TAP block w normal saline; Drug: TAP block w Liposomal bupivacaine

• Registration Number: NCT02847013
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Primary Completion: 2019-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo- Tap block w normal saline	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 Liposomal bupivacaine	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

Primary Outcome Measures

Name	Time	Method
Postoperative narcotic use	initial 48 hours postoperatively	Patient use of standard postoperative narcotics (percocet) will be measured.

Secondary Outcome Measures

Name	Time	Method
Subjective pain scores using 1-10 VAS system	initial 48 hours postoperatively	Subjective pain scores using 1-10 VAS system will be measured

Trial Locations

Locations (1)

Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States