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

NCT05891613 | Completed Phase 4 FDA Drug

• 1 other identifier: 21-007358
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Reduction

Outcome Measures

Primary Outcomes (1)

• Pain Scores in the first 72 hours post-operatively following breast reduction

  Measured using validated self-reported Numerical Pain Rating Scale (NPRS). Participants rate pain using a scale of 0=none and 10=most severe.

  72 hours post-operatively

Study Arms (2)

Control Breast Treatment Group: Bupivacaine Hydrochloride

ACTIVE COMPARATOR

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

Drug: Bupivacaine Hydrochloride

Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine Hydrochloride; Drug: Liposomal Bupivacaine

Interventions

Bupivacaine Hydrochloride 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

Control Breast Treatment Group: Bupivacaine Hydrochloride; Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

Liposomal Bupivacaine DRUG

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

Also known as: Exparel

Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Basel Sharaf, MD, DDS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: January 24, 2024
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)