Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Completed · Phase 4

Conditions studied: Macromastia, Post-operative Pain

In brief

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. Researchers will compare to see if patients who receive subpectoral bupivacaine have lower pain scores in the PACU, and lower use of narcotics post-operatively when compared to the control group who receive injectable saline.

Key facts

Study ID

NCT05898087

Run by

Connecticut Children's Medical Center

People needed

52

Starts

2022-04-01

Expected to finish

2026-05-08

Last updated by the study team

2026-07-31

Who can join

Age: 13 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify 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 may not qualify 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.
• 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

Where it is running

• Connecticut Children's — Farmington, Connecticut, United States
• Connecticut Children's — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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