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

Study 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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: TAP block w Liposomal bupivacaine
* Procedure: TAP block w normal saline


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo- Tap block w normal saline<br>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<br>* TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)<br>|
| Experimental: Intervention-Tap block w Liposomal bupivacaine<br>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<br>* TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)<br>* Other names: Exparel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative narcotic use | Patient use of standard postoperative narcotics (percocet) will be measured. | initial 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective pain scores using 1-10 VAS system | Subjective pain scores using 1-10 VAS system will be measured | initial 48 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postcesarean Section, Postoperative