Clinical trial NCT04558840: Enhanced Recovery After Bilateral Reduction Mammaplasty
Official title: Enhanced Recovery After Bilateral Reduction Mammaplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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,
* smokers,
* 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

Primary outcomes:
measure: Post-operative Pain Questionnaire
timeFrame: Day 0 - Day 7
Secondary outcomes:
measure: Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome
timeFrame: Day 0- Day 7
measure: Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey
timeFrame: Day 0- Day 7
measure: Post operative Quality of Life Questionnaire
timeFrame: Day 0- Day 7
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jeffrey Kenkel
role: PRINCIPAL_INVESTIGATOR
References: