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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Breast Reduction

Treatments: Drug: Liposomal Bupivacaine; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05891613

21-007358

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Control Breast Treatment Group: Bupivacaine Hydrochloride

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Liposomal Bupivacaine