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Clinical Trials/NCT02542956
NCT02542956
Withdrawn
Phase 4

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

Henry Ford Health System1 site in 1 countryOctober 2014
ConditionsPain
InterventionsExparelMarcaine

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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

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