Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine for Pain Management

Study Overview
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Brief Summary
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The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Detailed Description
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The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Official Title
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Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.

Conditions
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Pain

Intervention / Treatment
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* Drug: Exparel
* Drug: Marcaine
* Drug: Marcaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing abdominoplasty or TRAM flap breast reconstruction Exclusion Criteria: A medical condition that could interfere with study participation Body weight less than 50 kg Participating in another study involving an investigational medication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exparel<br>Injection of Exparel | Drug: Exparel<br>* receive Exparel by injection<br>|
| Active Comparator: Marcaine<br>Receive Marcaine in a pain pump or by injection | Drug: Marcaine<br>* receive Marcaine in a pain pump<br>Drug: Marcaine<br>* receive Marcaine by injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of Pain |  | 30 minute to 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tummy tuck (abdominoplasty), Breast Surgery