Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time to initiation of active trial of void
研究概览
简要总结
This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy) at South Shore Surgery Center
- •In good general health as evidenced by medical history
- •Ability to take oral medication and be willing to adhere to the study intervention
- •Patients may be English or Spanish-speaking and must be able to provide informed consent
排除标准
- •Pregnancy or lactation
- •Younger than age 18
- •Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
- •Patients with Myasthenia Gravis, renal disease with CrCl < 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), driving impairment, increased seizures suicidal behavior and respiratory depression.
- •Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment/hepatic disease, hyperkalemia.
- •Patients with compromised renal function who are notable to receive NSAIDs
- •Patients with significant cardiovascular disease, such as patients with heart failure
- •Patient with recent evidence of worsening fluid retention
- •Both non-English and non-Spanish speaking patients
- •Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis)
- •Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
- •Current use of gabapentin as home medication
研究组 & 干预措施
Standard of Care (SOC) (acetaminophen)
one time dose of 1000mg acetaminophen orally
干预措施: Acetaminophen (Drug)
Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)
one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally
干预措施: Acetaminophen (Drug)
Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)
one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally
干预措施: Celecoxib (Drug)
Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)
one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally
干预措施: Gabapentin (Drug)
结局指标
主要结局
Time to initiation of active trial of void
时间窗: through study completion, an average of 2 years
次要结局
未报告次要终点