Post-operative Pain Clinical Trial
Official title:
Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty
The goal of this randomized control trial is to in [describe participant population/health conditions]. The main question it 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 20cc of subpectoral bupivacaine injections or into the control group that intraoperatively receives 20cc 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.
Status | Recruiting |
Enrollment | 128 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. Female 2. Age 13-21 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 |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Children's | Farmington | Connecticut |
United States | Connecticut Children's | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative 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 | Narcotic use | Narcotic use will be determined by chart review of the PACU record. The amount of narcotic pain medication will be recorded for each patient. Prescription narcotic use upon discharge will be patient-reported in their patient log. | Measured up until 4 weeks post-op | |
Secondary | Length of stay in post-anesthesia care unit | Length of stay in post-anesthesia care unit will be determined by chart review from time entering the PACU to time of discharge from the hospital. | Measured on day of surgery | |
Secondary | Return to full activity | Return to full activity- will be categorized as returning to school, returning to light activity, or returning to full activity/heavy exercise. | Measured for 4 weeks post-op | |
Secondary | Demographics | Demographics including age, race, ethnicity will be collected and recorded for all patients approached to enter the study. | Recorded when patient is enrolled |
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