Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

NCT05898087 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-167-CCMC
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Macromastia; Post-operative Pain

Keywords

macromastia; post-operative pain; bupivacaine

Outcome Measures

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.

  Measured on day of surgery

Secondary Outcomes (4)

• Demographics

  Recorded when patient is enrolled

• Total Amount of Narcotic Use

  Measured up until 4 weeks post-op

• Days to Return to full activity

  Measured for 4 weeks post-op

• Length of stay in post-anesthesia care unit (hours)

  Measured on day of surgery

Study Arms (2)

Study Group 1 - Intervention

EXPERIMENTAL

Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia

Drug: Marcaine 0.25 % Injectable Solution

Study Group 2 - Control

PLACEBO COMPARATOR

Participants in this group will receive 20cc of subpectoral saline injected into the fascia

Drug: Saline

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

Also known as: bupivacaine 0.25% injectable solution

Study Group 1 - Intervention

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

Also known as: injectable saline

Study Group 2 - Control

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who are pregnant, determined by urine testing in pre-operative area.
• Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.
• Patients with significant post-operative complications
• Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (2)

Connecticut Children's

Farmington, Connecticut, 06032, United States

RECRUITING

Connecticut Children's

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (3)

• Wallace CC, Wetzel ME, Howell C, Vasconez HC. The Efficacy of Pectoralis Nerve Blockade in Breast Reductions: A Prospective Randomized Trial. Ann Plast Surg. 2021 Jun 1;86(6S Suppl 5):S632-S634. doi: 10.1097/SAP.0000000000002763.

  PMID: 33625027 RESULT

• Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.

  PMID: 15923838 RESULT

• Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.

  PMID: 18650606 RESULT

MeSH Terms

Conditions

Gigantomastia; Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christopher Hughes, MD, MPH

  Connecticut Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren C Schmidtberg, PA-C

CONTACT

860-545-9360; lschmidtberg@connecticutchildrens.org

Christopher Hughes, MD, MPH

CONTACT

860-545-9360; chughes02@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is blinded to enrollment group (study group vs control.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: June 12, 2023
• Study Start: April 1, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From beginning of enrollment until completion of the research paper.
• Access Criteria: Only researchers involved in the study will have access

Locations

US (2)