An interventional study of Macromastia in Pain, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Supportive care
This single-center, clinical trial is being conducted to determine whether non-narcotic pain regiments are as effective as narcotic-based regiments in reducing post-operative pain in patients undergoing breast reduction in the outpatient setting.
This is a non-blinded, non-inferiority, randomized control trial with the primary outcome of interest being overall pain, with secondary outcomes including adverse effects from pain medications, patient satisfaction with their pain regiment and with their surgery, and the impact of pain on their daily activities. This study is designed to follow one-hundred (100) qualified and consenting patients seeing the PI/surgeon (JMK) at his office at UT Southwestern for their initial operative consultation for macromastia. If patients meet eligibility criteria, they will be offered enrollment in the trial.
University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ERAS Arm will undergo multimodal regiment: Before Surgery- gabepentin 300mg and celecoxib 400mg once the day before surgery and again 3 hours prior to surgery. During surgery- subjects will receive ketorolac 30mg IV ketorolac once (15mg for patients age 64 years and above). Post-operatively- Gabapentin 100mg three times daily for POD0-7, ketorolac 10mg four times daily for POD1-5 days, and ondansetron 4mg as needed for nausea; patients will also have a prescription for hydrocodone-acetaminophen 5/325mg tabs that they may fill if needed for emergency/breakthrough pain.
Procedure: Macromastia
The current practice arm will include: post-operatively, hydrocodone-acetaminophen 5/325mg tabs and ibuprofen 800mg, as needed for pain. Additionally, acetaminophen may be used in conjunction with the above regiment. Ibuprofen and acetaminophen can be taken as needed or alternating every 6 hours, scheduled.
Procedure: Macromastia
Patients with macromastia seeing the principle investigator (PI) (JMK) at his office at the Outpatient Building, which includes the Outpatient Surgery Center (OSC), in the Department of Plastic Surgery clinic at UT-Southwestern for their initial operative consultation for reduction mammaplasty will be offered enrollment in the trial if they are deemed appropriate surgical candidates, based on the PI's clinical judgement and expertise.
Also known as: Mammaplasty
Post-operative Pain Questionnaire
Determine the efficacy of non-narcotic pain regiments in patients undergoing breast reduction surgery and compare it to narcotic-based pain regiments in improving post-operative pain in patients undergoing breast reduction surgery. Patients will be asked to rate their pain from a scale of 0 ("No Pain") to 10 ("Pain as bad as you can imagine").
Time frame: Day 0 - Day 7
Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome
The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST-Q Postoperative Reduction Module Satisfaction with Outcome. Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.
Time frame: Day 0- Day 7
Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey
The following questionnaires will be used to track the patients satisfaction following their procedure: BREAST- Q Postoperative Reconstruction Module Satisfaction with Information Survey. Patients will be asked to rate their satisfaction with: Very dissatisfied, Somewhat dissatisfied, Somewhat satisfied or very satisfied.
Time frame: Day 0- Day 7
Post operative Quality of Life Questionnaire
The following questionnaires will be used to track the patients satisfaction following their procedure. The postoperative questions do not have an applicable scale.
Time frame: Day 0- Day 7
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center