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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 - Intervention | Experimental | Participants in this group will receive 20cc of subpectoral bupivacaine injected into the fascia |
|
| Study Group 2 - Control | Placebo Comparator | Participants in this group will receive 20cc of subpectoral saline injected into the fascia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Demographics including age, race, ethnicity will be collected and recorded for all patients approached to enter the study. | Recorded when patient is enrolled |
| Total Amount of Narcotic Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren C Schmidtberg, PA-C | Contact | 860-545-9360 | lschmidtberg@connecticutchildrens.org | |
| Christopher Hughes, MD, MPH | Contact | 860-545-9360 | chughes02@connecticutchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Hughes, MD, MPH | Connecticut Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's | Recruiting | Farmington | Connecticut | 06032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33625027 | Result | 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. | |
| 15923838 | 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. |
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The research team is comprised of the medical providers caring for these patients. The study information will be collected and stored on the secure hospital server, password protected.
From beginning of enrollment until completion of the research paper.
Only researchers involved in the study will have access
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| ID | Term |
|---|---|
| C536821 | Gigantomastia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Participant is blinded to enrollment group (study group vs control.)
|
| 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 |
|
|
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 |
| Days to 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 |
| Length of stay in post-anesthesia care unit (hours) | 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 |
| Connecticut Children's | Recruiting | Hartford | Connecticut | 06106 | United States |
|
| 18650606 | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |