Enhanced Recovery After Bilateral Reduction Mammaplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Post-operative Pain Questionnaire
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
- •Age 18 and older
- •BMI less than 40, non-smokers.
Exclusion Criteria
- •age less than 18,
- •BMI over 40,
- •uncontrolled diabetes,
- •American Society of Anesthesiologists (ASA) status scores 3 or higher
- •patients with allergies to any of the medications in the ERAS or current practice regiments (gabapentin, celecoxib, ketorolac, ondansetron, or hydrocodone).
- •History of narcotic or IV drug abuse
- •History of chronic pain
- •Hypersensitivity or allergy to any of these drugs: gabapentin, celecoxib, ketorolac, hydrocodone, ibuprofen or acetaminophen
- •Current pregnancy or planning pregnancy in the next xx weeks/ months
- •Contraindications to NSAID drugs (ketorolac, ibuprofen, celecoxib): coagulation disorder, active bleeding, severe renal impairment, hepatic impairment.
- •Contraindications to gabapentin: caution for CrCl <60, caution in elderly, caution if alcohol consumption
- •Contraindications to acetaminophen: hepatic or renal impairment, chronic alcohol use
Outcomes
Primary Outcomes
Post-operative Pain Questionnaire
Time Frame: Day 0 - Day 7
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").
Secondary Outcomes
- Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey(Day 0- Day 7)
- Post operative Quality of Life Questionnaire(Day 0- Day 7)
- Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome(Day 0- Day 7)
Investigators
Jeffrey M. Kenkel
Chairman, Department of Plastic Surgery
University of Texas Southwestern Medical Center