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OpenTrials
Completed

NCT Number: NCT05891613

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

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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Key information

Conditions

Breast Reduction

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Liposomal bupivacaine

Drug

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

Other names: Exparel

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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