NCT02542956

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

4.2 years

First QC Date

September 3, 2015

Last Update Submit

January 28, 2022

Conditions

Pain

Keywords

Tummy tuck (abdominoplasty)Breast Surgery

Outcome Measures

Primary Outcomes (1)

  • Recurrence of Pain

    30 minute to 72 hours after surgery

Study Arms (2)

Exparel

ACTIVE COMPARATOR

Injection of Exparel

Drug: Exparel

Marcaine

ACTIVE COMPARATOR

Receive Marcaine in a pain pump or by injection

Drug: Marcaine

Interventions

ExparelDRUG

receive Exparel by injection

Exparel
MarcaineDRUG

receive Marcaine in a pain pump

Marcaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing abdominoplasty or TRAM flap breast reconstruction

You may not qualify if:

  • A medical condition that could interfere with study participation
  • Body weight less than 50 kg
  • Participating in another study involving an investigational medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Donna Tepper, M.D

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Plastic Surgeon

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

US(1)