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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Exparel; Drug: Marcaine

• Registration Number: NCT02542956
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exparel	Exparel	Injection of Exparel
Marcaine	Marcaine	Receive Marcaine in a pain pump or by injection

Primary Outcome Measures

Name	Time	Method
Recurrence of Pain	30 minute to 72 hours after surgery

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States