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

Penn State Health

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Pain

Treatments: Procedure: TAP block w normal saline; Drug: TAP block w Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02847013

00005133

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo- Tap block w normal saline

Placebo Comparator group

Description:

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

Treatment:

Procedure: TAP block w normal saline

Intervention-Tap block w Liposomal bupivacaine

Experimental group

Description:

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

Treatment:

Drug: TAP block w Liposomal bupivacaine