Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.
Overview
- Phase
- Phase 4
- Intervention
- Exparel
- Conditions
- Pain
- Sponsor
- Henry Ford Health System
- Locations
- 1
- Primary Endpoint
- Recurrence of Pain
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Donna Tepper M.D
Plastic Surgeon
Henry Ford Health System
Eligibility Criteria
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
Arms & Interventions
Exparel
Injection of Exparel
Intervention: Exparel
Marcaine
Receive Marcaine in a pain pump or by injection
Intervention: Marcaine
Outcomes
Primary Outcomes
Recurrence of Pain
Time Frame: 30 minute to 72 hours after surgery