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Bupivacaine Injection for Postoperative Pain in Breast Reduction

Phase 4
Recruiting
Led By Christopher Hughes, MD, MPH
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025
Female
Must not have
Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist
Patients with a history of hepatic or renal dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded when patient is enrolled
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial studies if a bupivacaine injection can reduce post-op pain in teens having breast reduction surgery. Patients will get injection or saline & be monitored for pain levels & narcotic use.

Who is the study for?
This trial is for female adolescents aged 13-21 undergoing breast reduction surgery at Connecticut Children's. They must be able to have a parent or guardian consent to the study. Excluded are those with substance use disorders, chronic pain managed by specialists, pre-surgery narcotic use, liver/kidney dysfunction, bupivacaine allergy, pregnancy, inability to report pain reliably, significant post-op complications or lost follow-up.
What is being tested?
The study tests if injecting bupivacaine (a numbing medication) under the chest muscle during surgery reduces post-operative pain and narcotic use compared to saline (saltwater solution). Participants will be randomly assigned to receive either bupivacaine or saline and will track their pain and medication usage for one week after surgery.
What are the potential side effects?
Possible side effects of subpectoral bupivacaine may include discomfort at injection site, numbness beyond desired effect area, weakness in muscles near injection site for a short period of time after surgery. Saline injections typically do not cause side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a breast reduction surgery at Connecticut Children's between 2022 and 2025.
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I am female.
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I am between 13 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of substance use disorder or chronic pain managed by a specialist.
Select...
I have had liver or kidney problems in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured on day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured on day of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Reported Pain Score
Secondary study objectives
Days to Return to full activity
Demographics
Length of stay in post-anesthesia care unit (hours)
+1 more

Awards & Highlights

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.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study Group 1 - InterventionExperimental Treatment1 Intervention
Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia
Group II: Study Group 2 - ControlPlacebo Group1 Intervention
Participants in this group will receive 20cc of subpectoral saline injected into the fascia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Marcaine 0.25 % Injectable Solution
2016
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor
73 Previous Clinical Trials
26,496 Total Patients Enrolled
Christopher Hughes, MD, MPHPrincipal InvestigatorConnecticut Children's

Media Library

Saline Clinical Trial Eligibility Overview. Trial Name: NCT05898087 — Phase 4
Breast Enlargement Research Study Groups: Study Group 1 - Intervention, Study Group 2 - Control
Breast Enlargement Clinical Trial 2023: Saline Highlights & Side Effects. Trial Name: NCT05898087 — Phase 4
Saline 2023 Treatment Timeline for Medical Study. Trial Name: NCT05898087 — Phase 4
~14 spots leftby Apr 2025
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