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Local Anesthetic
Pain Management After Breast Reduction
Phase 4
Recruiting
Led By Basel Sharaf, MD, DDS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post-operatively
Awards & highlights
Study Summary
This trial will compare the effectiveness of two types of pain relief medicine to see which is better for managing pain.
Who is the study for?
This trial is for adult women aged 18-70 with symptomatic macromastia who are scheduled for breast reduction surgery using a specific incision technique. It's not specified who can't join, but typically those with health conditions affecting the study outcome would be excluded.Check my eligibility
What is being tested?
The study compares pain control and opioid use after breast reduction surgery between two drugs: Liposomal Bupivacaine (Exparel) and standard Bupivacaine Hydrochloride. Participants will receive one of these medications to manage post-surgery pain.See study design
What are the potential side effects?
Possible side effects include discomfort at the injection site, nausea, vomiting, constipation from opioids if used for pain relief, and potential allergic reactions to the anesthetics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post-operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Scores in the first 72 hours post-operatively following breast reduction
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Breast Treatment Group: Liposomal (Exparel) BupivacaineExperimental Treatment2 Interventions
Subjects undergoing breast reduction surgery will receive a mixture of liposomal (Exparel) bupivacaine with plain 0.25% bupivacaine hydrochloride in contralateral breast.
Group II: Control Breast Treatment Group: Bupivacaine HydrochlorideActive Control1 Intervention
Subjects undergoing breast reduction surgery will receive standard 0.25% Bupivacaine Hydrochloride in one breast.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal Bupivacaine
2016
Completed Phase 4
~1540
Bupivacaine Hydrochloride
2020
Completed Phase 4
~1420
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,446 Total Patients Enrolled
Basel Sharaf, MD, DDSPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need daily pain medication for chronic pain.I have had radiation therapy to my chest before.I cannot have breast reduction due to my medical or surgical history.I am undergoing or have undergone a surgery not related to breast cancer.I am taking medication to prevent blood clots.I have had breast surgery, such as implants, reduction, or a lift.I am a woman aged 18-70 with large breasts causing symptoms, planning a specific breast reduction surgery.I have liver or kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Control Breast Treatment Group: Bupivacaine Hydrochloride
- Group 2: Treatment Breast Treatment Group: Liposomal (Exparel) Bupivacaine
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For whom is this clinical research program accessible?
"This clinical trial only accepts participants who have undergone breast reduction surgery and are aged between 18 and 70. 42 individuals need to be enrolled in this research initiative."
Answered by AI
Is it possible for geriatric participants to join this scientific endeavor?
"This research project is open to individuals aged 18 or above and younger than 70."
Answered by AI
Are there any remaining opportunities to join this research program?
"At current, clinicaltrials.gov has reported that this trial is not accepting any more participants. This medical study was first posted on July 1st 2023 and the last update to the listing occured on May 26th 2023. Nonetheless, there are still two other trials actively looking for patients at present."
Answered by AI
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