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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bupivacaine Pain Pumps to Decrease Mastectomy Post-Operative Pain

NCT01494259

Pain

WITHDRAWN PHASE4

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction

NCT02525718

Breast Cancer

COMPLETED PHASE2

Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction

NCT02662036

Mammaplasty

TERMINATED PHASE4

Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

NCT04278846

Pain, Postoperative Mammaplasty

COMPLETED PHASE4

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

NCT04284930

Pain, Postoperative

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exparel

Injection of Exparel

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

receive Exparel by injection

Marcaine

Receive Marcaine in a pain pump or by injection

Group Type ACTIVE_COMPARATOR

Marcaine

Intervention Type DRUG

receive Marcaine in a pain pump

Marcaine

Intervention Type DRUG

receive Marcaine by injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exparel

receive Exparel by injection

Intervention Type DRUG

Marcaine

receive Marcaine in a pain pump

Intervention Type DRUG

Marcaine

receive Marcaine by injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No