Enhanced Recovery After Bilateral Reduction Mammaplasty

Not Applicable

Terminated

• Conditions: Pain

• Registration Number: NCT04558840
• Lead Sponsor: University of Texas Southwestern Medical Center

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 Timeline

• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Study Start: 2021-10-15
• Primary Completion: 2023-05-09
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Questionnaire	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 Outcome Measures

Name	Time	Method
Post operative Patient Satisfaction Questionnaire: Postoperative Module Satisfaction with Information Survey	Day 0- Day 7	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.
Post operative Quality of Life Questionnaire	Day 0- Day 7	The following questionnaires will be used to track the patients satisfaction following their procedure.; The postoperative questions do not have an applicable scale.
Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome	Day 0- Day 7	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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States