Enhanced Recovery After Bilateral Reduction Mammaplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Post-operative Pain Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients undergoing bilateral breast reduction (reduction mammaplasty) with the PI in the outpatient setting
- •Age 18 and older
- •BMI less than 40, non-smokers.
排除标准
- •age less than 18,
- •BMI over 40,
- •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
结局指标
主要结局
Post-operative Pain Questionnaire
时间窗: 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").
次要结局
- 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)
- Post operative Patient Satisfaction Questionnaire: Postoperative Reduction Module Satisfaction with Outcome(Day 0- Day 7)
研究者
Jeffrey M. Kenkel
Chairman, Department of Plastic Surgery
University of Texas Southwestern Medical Center