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

Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride for Postoperative Analgesia After Breast Reduction Surgery: A Prospective, Single Blind, Non-randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05891613

Enrollment

Registered

2023-06-07

Start date

2024-01-24

Completion date

2025-10-06

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reduction

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.

Interventions

DRUGBupivacaine 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

DRUGLiposomal Bupivacaine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026