Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Study Overview
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Brief Summary
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Transversus Abdominis Plane (TAP) block is a useful tool in pain management after abdominal surgery. It is a regional nerve block that targets T6-L1 thoracolumbar nerves running in the plane between internal oblique and transversus abdominis muscle. It is shown to help with post-operative pain management, reducing pain scores and narcotic pain medication use, as well as promoting earlier return to activity and recovery. TAP block became a very popular, safe, and effective therapeutic adjunct for many different abdominal surgeries ranging from obstetric procedures to general surgery procedures like colorectal surgery. Furthermore, it is used in plastic surgery procedures such as Deep Inferior Epigastric Perforator (DIEP) free flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap, as they involve extensive amount of abdominal soft tissue incision. Previous studies have shown that TAP block in these procedures significantly reduce post-op pain and narcotic pain medication use. More recently, Exparel (liposomal bupivacaine) has risen to spotlight for providing a longer, sustained local anesthesia. Various surgical disciplines have adopted this agent as part of their pain management protocol. However, there are no literatures that describe the effect of TAP block using Exparel for breast free flap population. The study hypothesize that delivering TAP block with Exparel (vs. plain bupivacaine) will provide longer regional blocking effect, hence aiding in pain control and recovery postoperatively. The investigators will be analyzing postop narcotic pain medication requirement and pain scores to look into this question.

Official Title
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Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

Conditions
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Postoperative Pain, Breast Reconstruction

Intervention / Treatment
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* Drug: Liposomal bupivacaine TAP block
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center Exclusion Criteria: Subjects with ages <18 years Allergy to local anesthetic Inability to tolerate standard postoperative pain management regimen (Tylenol, Toradol, and Oxycodone PRN) for any reason Subjects who cannot read or understand English Subjects who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group: TAP block with plain bupivacaine Intervention group: TAP block with plain bupivacaine + liposomal bupivacaine
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - plain bupivacaine<br>Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively | Drug: Bupivacain<br>* Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.<br>|
| Experimental: Experimental - Liposomal bupivacaine<br>Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively | Drug: Liposomal bupivacaine TAP block<br>* Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-op pain scores during initial hospitalization | Visual analog pain scale (0-10) | During initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | 
| post-op narcotic pain medication use during hospitalization | total amount of morphine milliequivalent | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | 
| post-op narcotic pain medication use after discharge (within 30 days of discharge) | total amount of morphine milliequivalent | from the time of discharge to 30 days post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | hospital length of stay | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | 
| Incidence of Post-op nausea and vomiting (PONV) | Incidence of PONV | during initial hospitalization following surgery up to Day 5 (or to the point of discharge), whichever came first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP block, Regional block, ERAS, liposomal bupivacaine, free flap