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Exparel for Postoperative Pain in Breast Reconstruction

Phase 4

Waitlist Available

Led By John Stranix, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All female patients who are 18 years or older who will undergo unilateral or bilateral abdomen-based free flap breast reconstruction at UVA Medical Center

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of discharge to 30 days post discharge

Awards & highlights

Study Summary

This trial is looking at whether using a TAP block with Exparel (a long-acting local anesthetic) can help with pain management and recovery after breast free flap surgery.

Who is the study for?

This trial is for adult women undergoing abdomen-based free flap breast reconstruction at UVA Medical Center. Participants must be able to manage postoperative pain with standard medications and understand English. Pregnant women or those allergic to local anesthetics are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of Exparel (liposomal bupivacaine) TAP block versus plain bupivacaine in managing post-surgery pain for breast reconstruction patients. It aims to see if Exparel provides longer-lasting pain relief and reduces the need for narcotic pain medication.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, such as discomfort or infection, possible nerve damage, and systemic effects like dizziness or heart rhythm changes due to local anesthetic spreading.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18 planning a specific breast reconstruction at UVA Medical Center.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of discharge to 30 days post discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of discharge to 30 days post discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of discharge to 30 days post discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

post-op narcotic pain medication use after discharge (within 30 days of discharge)

post-op narcotic pain medication use during hospitalization

post-op pain scores during initial hospitalization

Secondary outcome measures

Incidence of Post-op nausea and vomiting (PONV)

Length of hospital stay

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental - Liposomal bupivacaineExperimental Treatment1 Intervention

Receives plain bupivacaine + liposomal bupivacaine TAP block as part of multi-modal pain control intraoperatively

Group II: Control - plain bupivacaineActive Control1 Intervention

Receives plain bupivacaine TAP block as part of multi-modal pain control intraoperatively

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,931 Total Patients Enrolled

1 Trials studying Postoperative Pain

70 Patients Enrolled for Postoperative Pain

John Stranix, MDPrincipal InvestigatorUniversity of Virginia

Media Library

Liposomal bupivacaine TAP block Clinical Trial Eligibility Overview. Trial Name: NCT04777591 — Phase 4

Postoperative Pain Research Study Groups: Experimental - Liposomal bupivacaine, Control - plain bupivacaine

Postoperative Pain Clinical Trial 2023: Liposomal bupivacaine TAP block Highlights & Side Effects. Trial Name: NCT04777591 — Phase 4

Liposomal bupivacaine TAP block 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777591 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have enrolled in this trial as of now?

"This clinical trial is no longer accepting candidates as of March 1st 2021. If you are searching for other medical studies, there are currently 534 trials recruiting patients with postoperative pain and 109 trials in search of participants for the Liposomal bupivacaine TAP block protocol."

Answered by AI

To what extent do the risks of Liposomal bupivacaine TAP block outweigh its potential benefits?

"There is a plethora of evidence supporting the safety profile of Liposomal bupivacaine TAP block, which has been approved by governing bodies. Thusly, this treatment was scored as 3 on our 1 to 3 scale."

Answered by AI

To what types of medical situations is Liposomal bupivacaine TAP block typically applied?

"Liposomal bupivacaine TAP block is regularly used to treat pemphigus and has been prescribed for conditions such as acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Are there any recorded precedents of clinical trials using Liposomal bupivacaine TAP block?

"Currently, 18 trials for Liposomal bupivacaine TAP block are in their final stage of development. Philadelphia is the epicentre for these studies; however, clinical research sites exist across 144 locations worldwide."

Answered by AI

Are recruitment efforts still in progress for this clinical trial?

"Unfortunately, this specific trial is no longer accepting patients. It was first posted on March 10th 2021 and updated for the last time a few weeks later on March 1st 2021. If you are looking for other trials related to postoperative pain there are currently 534 active studies while 109 research opportunities exist in regard to Liposomal bupivacaine TAP block treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction

John Stranix 2021. "Effectiveness of Exparel TAP Block in Breast Free Flap Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04777591.

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