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

Mayo Clinic32 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Reduction

Interventions

Bupivacaine HydrochlorideDRUG

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 BupivacaineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: 72 hours post-operatively

Data from ClinicalTrials.gov

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