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Enhanced Recovery After Bilateral Reduction Mammaplasty

NCT ID: NCT04558840

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enhanced Recovery After Surgery (ERAS) Arm

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.

Group Type ACTIVE_COMPARATOR

Macromastia

Intervention Type 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.

Current Practice Arm

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.

Group Type ACTIVE_COMPARATOR

Macromastia

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Mammaplasty

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey M. Kenkel

Chairman, Department of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey Kenkel

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU 2020-0813

Identifier Type: -

Identifier Source: org_study_id