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

Henry Ford Health logo

Henry Ford Health

Status and phase

Withdrawn
Phase 4

Conditions

Pain

Treatments

Drug: Exparel
Drug: Marcaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02542956
SR91333

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Exparel
Active Comparator group
Description:
Injection of Exparel
Treatment:
Drug: Exparel
Marcaine
Active Comparator group
Description:
Receive Marcaine in a pain pump or by injection
Treatment:
Drug: Marcaine
Drug: Marcaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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