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NCT02542956 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02542956
Other study ID # SR91333
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date October 2014
Est. completion date December 2018

Study information
Verified date January 2022
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Exparel
receive Exparel by injection
• Marcaine
receive Marcaine in a pain pump
• Marcaine
receive Marcaine by injection

Locations
Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of Pain 30 minute to 72 hours after surgery
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