A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Change in Pain (VAS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Opioid Group
Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
干预措施: Oxycodone 5 mg Oral Tablet (Drug)
Placebo Group
Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in Pain (VAS) Score
时间窗: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months, 24 months, and 60 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
次要结局
- Change in patient Satisfaction Scores(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(Baseline, 60 months post operative)
- Change in associated side effects(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(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative)
- Change in American Shoulder and Elbow Surgeons Index Scale (ASES)(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)(baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative)
- Length of stay postoperative(End of the trial (up to 60 months post operative))
- Number of complications(End of the trial (up to 60 months post operative))
研究者
Eric Wagner
Assistant Professor
Emory University