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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Marcaine 0.25 % Injectable Solution
DrugPatients in this arm will receive an injection of 20cc of injectable 0.25% bupivacaine solution. It will be injected in a fan-like pattern beneath the pectoralis fascia
Saline
DrugPatients in this arm will receive an injection of 20cc of injectable saline. It will be injected in a fan-like pattern beneath the pectoralis fascia
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Study Group 1 - InterventionExperimental treatment 1 intervention
Group B: Study Group 2 - ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Reported Pain Score
Post-operative pain score will be patient reported on a rating scale of 1-10. This will be recorded by the PACU nurse upon admission and upon discharge from the PACU. Patients will subsequently record a daily pain score in a home log daily until their 1 week follow-up visit. Scores will be recorded using the home log provided by the patient. We will also utilize chart review to record PACU pain score from the immediate post-operative time period.
Time frame
Measured on day of surgerySecondary outcomes
1
Demographics
Demographics including age, race, ethnicity will be collected and recorded for all patients approached to enter the study.
Time frame
Recorded when patient is enrolled2
Total Amount of Narcotic Use
Narcotic use will be determined by chart review of the PACU record. The amount of narcotic pain medication will be recorded for each patient. Prescription narcotic use upon discharge will be patient-reported in their patient log.
Time frame
Measured up until 4 weeks post-op3
Days to Return to full activity
Return to full activity- will be categorized as returning to school, returning to light activity, or returning to full activity/heavy exercise.
Time frame
Measured for 4 weeks post-op4
Length of stay in post-anesthesia care unit (hours)
Length of stay in post-anesthesia care unit will be determined by chart review from time entering the PACU to time of discharge from the hospital.
Time frame
Measured on day of surgerySponsors and contacts
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Source ClinicalTrials.gov