Enhanced Recovery After Bilateral Reduction Mammaplasty

NCT04558840 | Terminated

• 1 other identifier: STU 2020-0813
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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").

  Day 0 - Day 7

Secondary Outcomes (3)

• Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome

  Day 0- Day 7

• 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

Study Arms (2)

Enhanced Recovery After Surgery (ERAS) Arm

ACTIVE COMPARATOR

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

Current Practice Arm

ACTIVE COMPARATOR

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

Interventions

Macromastia PROCEDURE

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

Current Practice Arm; Enhanced Recovery After Surgery (ERAS) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
• Age 18 and older
• BMI less than 40, non-smokers.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Jeffrey Kenkel

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Plastic Surgery

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 22, 2020
• Study Start: October 15, 2021
• Primary Completion: May 9, 2023
• Study Completion: November 30, 2023
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (1)