Opioid-Free Orthopaedics

Официальное название

A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures

Обзор

The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Подробное описание

Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Вмешательства

• Препарат Oxycodone 5 mg Oral Tablet
  Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
• Препарат Placebo oral tablet
  Encapsulated placebo tablets x24, to take po q6 hours as need for pain

Первичные конечные точки

• Change in Pain (VAS) Score [Срок оценки: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative]

Вторичные конечные точки (8)

• Change in patient Satisfaction Scores [Срок оценки: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative]
• Change in opioid consumption [Срок оценки: Baseline, 60 months post operative]
• Change in associated side effects [Срок оценки: Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative]
• Change in Single Assessment Numeric Evaluation (SANE) score [Срок оценки: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative]
• Change in American Shoulder and Elbow Surgeons Index Scale (ASES) [Срок оценки: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative]
• Change in European Quality of Life 5 dimension (EQ-5D) [Срок оценки: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative]
• Length of stay postoperative [Срок оценки: End of the trial (up to 60 months post operative)]
• Number of complications [Срок оценки: End of the trial (up to 60 months post operative)]

Критерии участия

Критерии включения

• Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
• Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
• Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
• Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
• Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Критерии исключения

• Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
• Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
• Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• The Emory Clinic — Atlanta
• Emory University Hospital — Atlanta
• Emory Orthopedic and Spine Hospital — Tucker

Идентификаторы

NCT: NCT04659317 · STUDY00000478

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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