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New treatment option for Macromastia
Official title Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
ClinicalTrials.gov ID: NCT05898087
What this study is testing
What is Marcaine 0.25 % Injectable Solution?
Marcaine 0.25 % Injectable Solution is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for macromastia.
Also referred to as bupivacaine 0.25% injectable solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main question this randomized control trial aims to answer is: Is the use of intraoperative subpectoral bupivacaine associated with decreased post-operative pain in adolescent patients who undergo bilateral reduction mammaplasty Participants will be randomized into the study group that intraoperatively receives 30cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 30cc of injectable saline subpectorally. All participants will keep a pain log and pain medication log at home for the first week following surgery.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 25. Healthy volunteers may be eligible.
You may be able to join if
- Female
- Age 13-25 at the time of surgery
- Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
- Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
You likely can't join if
- Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
- Patients already taking narcotics at the time of surgery.
- Patients with a history of hepatic or renal dysfunction.
- Patients with known allergy to bupivacaine.
- Patients who are pregnant, determined by urine testing in pre-operative area.
- Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.
See the full eligibility criteria
- Female
- Age 13-25 at the time of surgery
- Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
- Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
- Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
- Patients already taking narcotics at the time of surgery.
- Patients with a history of hepatic or renal dysfunction.
- Patients with known allergy to bupivacaine.
- Patients who are pregnant, determined by urine testing in pre-operative area.
- Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.
- Patients with significant post-operative complications
- Patients not meeting inclusion criteria.
- Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively
The study team makes the final eligibility decision.
Where it's taking place
- Farmington, Connecticut, United States
- Hartford, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 25 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Farmington, Connecticut, United States; Hartford, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.