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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02847013
• Other study ID #: 00005133
• Status: Withdrawn
• Phase: Phase 2/Phase 3

Study information

• Verified date: January 2020
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain

Intervention

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

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

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative narcotic use	Patient use of standard postoperative narcotics (percocet) will be measured.	initial 48 hours postoperatively
Secondary	Subjective pain scores using 1-10 VAS system	Subjective pain scores using 1-10 VAS system will be measured	initial 48 hours postoperatively