RECRUITING

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty

Quick Facts

Study Start:2022-04-01
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05898087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female
  2. 2. Age 13-25 at the time of surgery
  3. 3. Undergoing bilateral reduction mammaplasty at Connecticut Children's from 1/1/2022-12/31/2025.
  4. 4. Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document.
  1. 1. Patients with history of substance use disorder or "chronic pain" defined as pain requiring management and treatment by a pain management specialist.
  2. 2. Patients already taking narcotics at the time of surgery.
  3. 3. Patients with a history of hepatic or renal dysfunction.
  4. 4. Patients with known allergy to bupivacaine.
  5. 5. Patients who are pregnant, determined by urine testing in pre-operative area.
  6. 6. Patients who are non-verbal or have developmental delays that would result in inability to report reliable pain scores.
  7. 7. Patients with significant post-operative complications
  8. 8. Patients not meeting inclusion criteria.
  9. 9. Patients lost to follow-up- they must be seen within 1 week and 4 weeks post-operatively

Contacts and Locations

Study Contact

Lauren C Schmidtberg, PA-C
CONTACT
860-545-9360
lschmidtberg@connecticutchildrens.org
Christopher Hughes, MD, MPH
CONTACT
860-545-9360
chughes02@connecticutchildrens.org

Principal Investigator

Christopher Hughes, MD, MPH
PRINCIPAL_INVESTIGATOR
Connecticut Children's

Study Locations (Sites)

Connecticut Children's
Farmington, Connecticut, 06032
United States
Connecticut Children's
Hartford, Connecticut, 06106
United States

Collaborators and Investigators

Sponsor: Connecticut Children's Medical Center

  • Christopher Hughes, MD, MPH, PRINCIPAL_INVESTIGATOR, Connecticut Children's

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-01
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2022-04-01
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • macromastia
  • post-operative pain
  • bupivacaine

Additional Relevant MeSH Terms

  • Macromastia
  • Post-operative Pain