NCT05891613

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Reduction

Interventions

Type	Name	Description
DRUG	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
DRUG	Liposomal Bupivacaine	20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast

Timeline

• Start date: 2024-01-24
• Primary completion: 2025-10-06
• Completion: 2025-10-06
• First posted: 2023-06-07
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study