Enhanced Recovery After Bilateral Reduction Mammaplasty

The University of Texas System (UT)

Status: Terminated

Conditions: Pain

Treatments: Procedure: Macromastia

Study type: Interventional

Funder types: Other

Identifiers

NCT04558840

STU 2020-0813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Enhanced Recovery After Surgery (ERAS) Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Macromastia

Current Practice Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Macromastia