Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

Study Overview
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Brief Summary
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This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.

Official Title
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A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

Conditions
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Mammaplasty

Intervention / Treatment
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* Drug: Bupivicaine HCL
* Drug: Liposomal bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM). At least 18 years of age. Female. Able to understand and willing to sign a written informed consent document. Exclusion Criteria: Cognitive impairment. History of abdominal surgery precluding free flap donor site. Allergy or intolerance to bupivacaine or amide anesthetics. Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months. Pregnant or breastfeeding.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Bupivicaine<br>-TAP block of 30 cc of 0.25% bupivicaine | Drug: Bupivicaine HCL<br> <br> * Other names: Bupivicaine;|
| Experimental: Group 2: Liposomal bupivacaine<br>-TAP block of 266 mg/30 cc liposomal bupivacaine | Drug: Liposomal bupivacaine<br> <br> * Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay |  | Up to day of discharge from hospital (expected hospital stay of 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay |  | Up to day of discharge from hospital (expected hospital stay of 5 days) | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay |  | Up to day of discharge from hospital, up to 7 days | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation |  | Up to 2 weeks post-operation | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter |  | Up to 2 weeks post-operation | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | Pain scale uses Wong-Baker FACES Pain Rating Scale The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain | 12 hours after surgery | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | Pain scale uses Wong-Baker FACES Pain Rating Scale The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain | 24 hours after surgery | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | Pain scale uses Wong-Baker FACES Pain Rating Scale The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain | 48 hours after surgery | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores | Pain scale uses Wong-Baker FACES Pain Rating Scale The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain | 72 hours after surgery | 
| Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery | Quality of Recovery -15 questionnaire Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time. The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling | At post operative day 2, discharge, and at 1-2 week follow-up | 
| Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics |  | Up to 2 weeks post-operation |