Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT05898087
Phase
PHASE4
Status
Recruiting
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Conditions

  • Macromastia
  • Post-operative Pain

Eligibility Criteria

Sex
ALL
Age
13 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Marcaine 0.25 % Injectable Solution — DRUG
    Patients 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 — DRUG
    Patients 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

Study Details

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 Dates

Start date
Apr 1, 2022
Status verified
May 2025
Primary completion
Apr 1, 2026
Completion
Apr 1, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study Group 1 - Intervention
    Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia
  • Placebo Comparator: Study Group 2 - Control
    Participants in this group will receive 20cc of subpectoral saline injected into the fascia

Primary Outcome Measure

Patient Reported Pain Score [ Time Frame: Measured on day of surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Connecticut Children'sFarmingtonConnecticut06032
Lauren C Schmidtberg
[email protected]
860-545-9360
Connecticut Children'sHartfordConnecticut06106
Lauren C Schmidtberg
[email protected]
860-545-9360

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