Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13-25
SponsorConnecticut Children's Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Marcaine 0.25 % Injectable Solution
- Saline
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov