Breast ReductionPhase 4NCT05891613

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

A Phase 4 study testing Bupivacaine Hydrochloride and Liposomal Bupivacaine in people with Breast Reduction, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Reduction
What is being tested?: Bupivacaine Hydrochloride and Liposomal Bupivacaine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2024to 6 Oct 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Minnesota
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Breast Reduction
Being tested: Bupivacaine Hydrochloride, Liposomal Bupivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine HydrochlorideDrug
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 BupivacaineDrug
Also called Exparel
20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast

Study groups in NCT05891613
Study group	Role	What they receive
Control Breast Treatment Group: Bupivacaine Hydrochloride	Active comparator	Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast. Receives: Drug: Bupivacaine Hydrochloride
Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine	Experimental	Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast. Receives: Drug: Bupivacaine Hydrochloride; Drug: Liposomal Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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, with higher scores indicating more severe pain.
Measured: 24 hours post-operatively, 48 hours post-operatively, 72 hours post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20246 Oct 2025

First posted7 Jun 2023
Study start24 Jan 2024
Primary completion6 Oct 2025
Study completion6 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast ReductionStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05891613
Sponsor's protocol ID: 21-007358
Status last verified: Oct 2026
First submitted: 26 May 2023
Last updated: 29 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liposomal Bupivacaine Versus 0.25% Bupivacaine Hydrochloride for Postoperative Analgesia After Breast Reduction Surgery: A Prospective, Single Blind, Non-randomized Controlled Trial
ClinicalTrials.gov ID: NCT05891613
Acronym / sponsor ID: 21-007358
Conditions: Breast Reduction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 24 Jan 2024 (actual)
Primary completion: 6 Oct 2025 (actual)
Study completion: 6 Oct 2025 (actual)
First posted: 7 Jun 2023 (actual)
Results: Posted 29 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control Breast Treatment Group: Bupivacaine Hydrochloride	Active comparator	Drug: Bupivacaine HydrochlorideSubjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.
Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine	Experimental	Drug: Bupivacaine Hydrochloride, Drug: Liposomal BupivacaineSubjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult female patients (18-70 years old) with symptomatic macromastia scheduled for breast reduction using a Wise pattern incision design.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine Hydrochloride20 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	Control Breast Treatment Group: Bupivacaine Hydrochloride, Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine
Liposomal BupivacaineAlso: Exparel20 ml of Liposomal (Exparel) Bupivacaine (266 mg/20 ml) on the contralateral breast	Drug	Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine

Primary outcome

Pain Scores in the First 72 Hours Post-operatively Following Breast Reduction
Time frame: 24 hours post-operatively, 48 hours post-operatively, 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, with higher scores indicating more severe pain.

Results and safety

Results posted to the registry on 29 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Breast Treatment Group: Bupivacaine Hydrochloride	32	32
Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine	32	32

Primary outcome: Pain Scores in the First 72 Hours Post-operatively Following Breast Reduction

Time frame: 24 hours post-operatively, 48 hours post-operatively, 72 hours post-operatively. Mean (Standard Deviation). Unit: score on a scale

Measure	Control Breast Treatment Group: Bupivacaine Hydrochloride n = 32	Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine n = 32
24 hours post-operatively AM	3.07 (2.04)	2.28 (1.85)
24 hours post-operatively PM	3.1 (2.3)	2.3 (1.5)
48 hours post-operatively AM	2.9 (2.41)	2.0 (1.74)
48 hours post-operatively PM	2.5 (2.2)	2 (1.7)
72 hours post-operatively AM	2.1 (1.7)	1.9 (1.6)
72 hours post-operatively PM	1.6 (1.6)	1.5 (1.5)

Adverse events

Time frame: From enrollment to end of follow-up, approximately 3 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Basel Sharaf, MD, DDS principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine Hydrochloride and Liposomal Bupivacaine in people with Breast Reduction, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Scores in the First 72 Hours Post-operatively Following Breast Reduction (time frame: 24 hours post-operatively, 48 hours post-operatively, 72 hours post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891613.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.