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

NCT02847013 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 00005133
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Postcesarean Section; Postoperative

Outcome Measures

Primary Outcomes (1)

• Postoperative narcotic use

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

  initial 48 hours postoperatively

Secondary Outcomes (1)

• Subjective pain scores using 1-10 VAS system

  initial 48 hours postoperatively

Study Arms (2)

Placebo- Tap block w normal saline

PLACEBO COMPARATOR

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

Intervention-Tap block w Liposomal bupivacaine

EXPERIMENTAL

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

Interventions

TAP block w Liposomal bupivacaine DRUG

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

Also known as: Exparel

Intervention-Tap block w Liposomal bupivacaine

TAP block w normal saline PROCEDURE

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

Placebo- Tap block w normal saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaimey Pauli, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OB/GYN Resident

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: July 27, 2016
• Primary Completion: December 17, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

US (1)