NCT05898087 Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
| NCT ID | NCT05898087 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Connecticut Children's Medical Center |
| Condition | Macromastia |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2022-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Female 2. Age 13-25 at the time of surgery 3. Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025. 4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist. 2. Patients already taking narcotics at the time of surgery. 3. Patients with a history of hepatic or renal dysfunction. 4. Patients with known allergy to bupivacaine. 5. Patients who are pregnant, determined by urine testing in pre-operative area. 6. Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores. 7. Patients with significant post-operative complications 8. Patients not meeting inclusion criteria. 9. Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively
Contact & Investigator
Christopher Hughes, MD, MPH
PRINCIPAL INVESTIGATOR
Connecticut Children's
Frequently Asked Questions
Who can join the NCT05898087 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 25 Years, studying Macromastia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05898087 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05898087 currently recruiting?
Yes, NCT05898087 is actively recruiting participants. Contact the research team at lschmidtberg@connecticutchildrens.org for enrollment information.
Where is the NCT05898087 trial being conducted?
This trial is being conducted at Farmington, United States, Hartford, United States.
Who is sponsoring the NCT05898087 clinical trial?
NCT05898087 is sponsored by Connecticut Children's Medical Center. The principal investigator is Christopher Hughes, MD, MPH at Connecticut Children's. The trial plans to enroll 128 participants.