drugset / Trial / NCT05898087

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

NCT05898087 ↗

Phase 4 Recruiting 128 enrolled Connecticut Children's Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2022-04-01
Primary completion
2026-04-01
Completion
2026-04-01

Outcome

Missed primary endpoint

paper No statistically significant difference was shown between the group receiving the Pecs blocks and the control with regard to narcotic requirements, pain scores PMID 33625027 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 20 ml Other

Indications