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

Phase 4

Recruiting

• Conditions: Breast Reduction
• Interventions: Drug: Bupivacaine Hydrochloride; Drug: Liposomal Bupivacaine

• Registration Number: NCT05891613
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-07
• Study Start: 2024-01-24
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine	Liposomal Bupivacaine	Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.
Control Breast Treatment Group: Bupivacaine Hydrochloride	Bupivacaine Hydrochloride	Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.
Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine	Bupivacaine Hydrochloride	Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.

Primary Outcome Measures

Name	Time	Method
Pain Scores in the first 72 hours post-operatively following breast reduction	72 hours post-operatively	Measured using validated self-reported Numerical Pain Rating Scale (NPRS). Participants rate pain using a scale of 0=none and 10=most severe.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States