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

Breast Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891613
• Other study ID #: 21-007358
• Status: Recruiting
• Phase: Phase 4
• Start date: January 24, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: BMSO Research Team
• Phone: 507-538-4849
• Email: BMSORESEARCH[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Reduction

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72 hours post-operatively