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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05891613

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Reduction	Drug: Bupivacaine Hydrochloride Drug: Liposomal Bupivacaine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Breast Treatment Group: Bupivacaine Hydrochloride Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.	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
Experimental: Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine 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 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 Drug: Liposomal Bupivacaine 20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast Other Names: Exparel

Arm

Intervention/Treatment

Active Comparator: Control Breast Treatment Group: Bupivacaine Hydrochloride

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

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

Experimental: Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

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

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

Drug: Liposomal Bupivacaine

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

Other Names:

Exparel

Outcome Measures

Primary Outcome Measures

Pain Scores in the first 72 hours post-operatively following breast reduction [72 hours post-operatively]
Measured using validated self-reported Numerical Pain Rating Scale (NPRS). Participants rate pain using a scale of 0=none and 10=most severe.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Minnesota	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Basel Sharaf, MD, DDS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Basel A. Sharaf, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05891613

Other Study ID Numbers:

21-007358

First Posted:

Jun 7, 2023

Last Update Posted:

Jun 7, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Jun 7, 2023