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

RECRUITING

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

Conditions:

🦠 Breast Reduction

🗓️ Study Start (Actual) 24 January 2024

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2024

👥 Enrollment (Estimated) 42

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE4

Locations:

📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

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.

Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 26 May 2023
First Submitted that Met QC Criteria 26 May 2023
First Posted 7 June 2023

Study Record Updates