Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

Официальное название

Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Acetaminophen
  Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
• Препарат Celecoxib
  Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
• Препарат Gabapentin
  Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

Первичные конечные точки

• Time to initiation of active trial of void [Срок оценки: through study completion, an average of 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Northwell Health South Shore Surgery Center — Bay Shore

Идентификаторы

NCT: NCT06379425 · 23-0050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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