Using bupivacaine to manage pain after breast reduction surgery in adolescents

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

This study is testing if a pain relief injection given during breast reduction surgery can help young women aged 13-25 feel less pain afterwards.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 13 Years to 25 Years
• Sex: All
• Sponsor: Connecticut Children's Medical Center (other)
• Locations: 2 sites (Farmington, Connecticut and 1 other locations)
• Trial ID: NCT05898087 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether administering subpectoral bupivacaine during bilateral reduction mammaplasty can reduce post-operative pain in adolescent females aged 13-25. Participants will be randomly assigned to receive either bupivacaine or saline injections during surgery, and their pain levels will be monitored through logs for one week post-operation. The study aims to compare pain scores and narcotic usage between the two groups to determine the effectiveness of bupivacaine in pain management.

Who should consider this trial

Good fit: Ideal candidates are females aged 13-25 who are scheduled for bilateral reduction mammaplasty at Connecticut Children's Medical Center.

Not a fit: Patients with a history of substance use disorder, chronic pain, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce post-operative pain and narcotic use in adolescent patients undergoing breast reduction surgery.

How similar studies have performed: Previous studies have shown promising results with the use of bupivacaine for pain management in surgical settings, suggesting potential success for this approach.

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

Where this trial is running

Farmington, Connecticut and 1 other locations

• Connecticut Children's — Farmington, Connecticut, United States (RECRUITING)
• Connecticut Children's — Hartford, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Christopher Hughes, MD, MPH — Connecticut Children's
• Study coordinator: Lauren C Schmidtberg, PA-C

Conditions: Macromastia, Post-operative Pain, macromastia, post-operative pain, bupivacaine