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

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to assess pain scores and opioid use when using Liposomal (Exparel) Bupivacaine versus Bupivacaine Hydrochloride.

Detailed 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.

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

Conditions
-----------------
Breast Reduction

Intervention / Treatment
-----------------
* Drug: Bupivacaine Hydrochloride
* Drug: Liposomal Bupivacaine


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Breast Treatment Group: Bupivacaine Hydrochloride<br>Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast. | Drug: Bupivacaine Hydrochloride<br>* 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<br>|
| Experimental: Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine<br>Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast. | Drug: Bupivacaine Hydrochloride<br>* 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<br>Drug: Liposomal Bupivacaine<br>* 20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast<br>* Other names: Exparel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |