A Study of Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride Post Breast Reduction

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2025-10-06

Brief Summary

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The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

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Detailed Description

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This is a prospective, multi-surgeon, single blind, non-randomized, controlled trial with breasts allocated to two parallel groups: A mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride will be used on one side (Treatment side) as local infiltration, and plain 0.25% Bupivacaine Hydrochloride will be used in the control arm. Each breast will serve as the control for the other. The study is designed to evaluate early postoperative pain control of each of the products up to 72 hours postoperatively. These treatments are standard of care in clinical practice.

Conditions

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Breast Reduction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Breast Treatment Group: Bupivacaine Hydrochloride

Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

20 ml of 0.25% Bupivacaine (50 mg) with 20 ml of injectable saline (total of 40 cc) as a subcutaneous infiltration along the inframammary fold incision on one breast

Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.

Group Type EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type DRUG

20 ml of 0.25% Bupivacaine (50 mg) with 20 ml of injectable saline (total of 40 cc) as a subcutaneous infiltration along the inframammary fold incision on one breast

Liposomal Bupivacaine

Intervention Type DRUG

20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast

Interventions

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Bupivacaine Hydrochloride

20 ml of 0.25% Bupivacaine (50 mg) with 20 ml of injectable saline (total of 40 cc) as a subcutaneous infiltration along the inframammary fold incision on one breast

Intervention Type DRUG

Liposomal Bupivacaine

20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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Inclusion Criteria

\- Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Exclusion Criteria

* Inability to provide informed consent
* Medical or surgical history precluding breast reduction
* History of significant chronic pain requiring daily use of opioid or nonopioid analgesics
* Pregnancy
* Concomitant non-breast surgical procedure
* Previous chest wall irradiation
* Previous breast implant, breast reduction or breast lift surgery
* Known allergy to bupivacaine or liposomal bupivacaine
* Liver or kidney dysfunction
* Use of antiplatelet or anticoagulation therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes