Intraoperative TAP Block After Repeat Cesarean

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Detailed Description
-----------------
Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Official Title
-----------------
Intraoperative Surgeon Administered Transversus Abdominis Plan (TAP) Block With Liposomal Bupivacaine and Post-operative Pain Control After Repeat Cesarean Delivery

Conditions
-----------------
Post-operative Pain

Intervention / Treatment
-----------------
* Procedure: TAP Block Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age. Pregnancy and delivery care obtained at UMass Memorial Medical Center Patients able to provide written informed consent English, Spanish, or Portuguese-speaking patients Exclusion Criteria: Participants who are under the age of 18 years Active labor. Baseline pain score > 6. Unable to provide informed consent. Prisoners will be excluded from this research. Narcotic use in the 2 weeks prior to delivery. Active substance abuse. Inability to take narcotic analgesia.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP Block Group<br>Participants will receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery. | Procedure: TAP Block Group<br>* Participants will receive a surgeon administered TAP block.<br>|
| No Intervention: Standard of Care Postoperative Pain Control<br>Participants will not receive a surgeon administered TAP block consisting of liposomal bupivacaine during their repeat cesarean delivery and will receive the routine standard of care for post-operative pain control. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Narcotic Use in Morphine Equivalents | Daily Narcotic Use in Morphine Equivalents | From time of surgery through postpartum day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first administered narcotic (oral or parental) | Time to first administered narcotic (oral or parental) post cesarean delivery | From time of surgery through postpartum day 4 | 
| Daily Average Pain Score | Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain | From time of surgery through postpartum day 4 | 
| Daily Maximum Pain Score | Daily Average Pain Score based on ten point pain scale (minimum 0, maximum 10) with higher numbers indicating worse pain | From time of surgery through postpartum day 4 | 
| Time to First Ambulation | Time to First Ambulation post cesarean delivery | From time of surgery through postpartum day 4 | 
| Time to First Solid Food | Time to First Solid Food | From time of surgery through postpartum day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, post-operative pain, TAP block