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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up recorded when patient is enrolled
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative pain score
Secondary outcome measures
Demographics
Length of stay in post-anesthesia care unit
Narcotic use
+1 more

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
71 Previous Clinical Trials
31,386 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this clinical experiment?

"According to clinicaltrials.gov, this study is currently searching for potential participants. This medical trial was initially posted on April 1st 2022 and amended most recently on May 26th 2023."

Answered by AI

Is the eligibility age for this clinical trial restricted to those 25 and under?

"According to the requirements listed, only individuals between 13 and 25 years old can join this medical study. Furthermore, 67 trials are open for children under 18 while 397 studies focus on elderly persons over 65 years of age."

Answered by AI

Is my participation possible in this investigation?

"To meet the qualifications of this investigation, individuals must have gynecomastia and be between 13 to 25 years old. Our team is hoping to recruit 128 eligible patients for participation."

Answered by AI

How many participants have contributed to this research initiative?

"Affirmative. Clinicaltrials.gov confirms that this research endeavour, which was initially published on April 1st 2022, is actively recruiting patients for participation. Approximately 128 volunteers are needed at two different medical centres."

Answered by AI

Has the FDA granted its seal of approval to Study Group 1 - Intervention?

"With the drug already approved, Study Group 1 - Intervention earns a score of 3 out of 3 in terms of safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
Christopher Hughes 2022. "Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05898087.
~39 spots leftby Apr 2025
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