Nonopioid Analgesia After Labral Surgery

Официальное название

Traditional vs. Nonopioid Analgesia After Labral Surgery

Обзор

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Подробное описание

Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.

Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia

Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.

Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.

Вмешательства

• Препарат Celecoxib
  Post-Operative Non Opioid Pain Protocol
• Препарат Hydrocodone-Acetaminophen
  Traditionally used narcotic pain protocol
• Препарат Ketorolac
  Post-Operative Non Opioid Pain Protocol
• Препарат Gabapentin
  Post-Operative Non Opioid Pain Protocol
• Препарат Acetaminophen
  Post-Operative Non Opioid Pain Protocol
• Препарат Diazepam
  Post-Operative Non Opioid Pain Protocol

Первичные конечные точки

• Pain Levels [Срок оценки: 10 days post-operatively]
• Patient-Reported Outcomes Measurement Information System [Срок оценки: 10 days post-operatively]

Критерии участия

Eligibility Criteria:

Критерии включения

• All adult patients over age 18 and scheduled for a primary or revision labral surgery

Критерии исключения

• Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Henry Ford Health System — Detroit

Идентификаторы

NCT: NCT03825809 · 1231914

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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