Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Daily Pain Scores (Numeric Rating Scale, NRS)
概览
简要总结
The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis.
The main questions it aims to answer are:
- Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription?
- Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?
详细描述
This study evaluates whether an opioid-sparing postoperative regimen can reduce opioid use while maintaining effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. Although opioids are commonly used after joint replacement, they carry risks such as side effects and long-term dependence. Multimodal analgesic strategies-using combinations of non-opioid medications and local anesthetic techniques-have shown promise in reducing opioid requirements while providing adequate pain relief.
All participants in this randomized, double-blind trial will receive a standardized multimodal non-opioid pain regimen throughout the perioperative period, along with counseling from a Life Care Specialist. Participants will be assigned to receive either a standard opioid prescription or placebo tablets at discharge, with a small supply of rescue hydromorphone available for severe breakthrough pain. Pain scores, nausea, opioid consumption, and patient-reported outcomes will be collected during the first postoperative week and at follow-up visits at 3 weeks and 3 months. The study aims to determine whether limiting routine opioid prescribing after hip arthroplasty can safely reduce opioid exposure without compromising recovery or patient satisfaction.
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
- Triple (Participant, 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
- •Diagnosis of hip osteoarthritis requiring primary arthroplasty
- •Scheduled to undergo anterior total hip arthroplasty (THA)
- •Able to comply with study procedures and follow-up visits
- •Able to provide informed consent
排除标准
- •Concurrent significant injuries to other bones or organs
- •Local infection at or near the surgical site
- •Preoperative opioid use within 4 weeks prior to surgery
- •History of severe heart disease (NYHA Class II or higher), renal failure, or liver dysfunction
- •Chronic liver disease
- •Neurological or psychiatric conditions that may influence pain perception
- •Pregnancy
- •History of alcohol or medication abuse
- •Inability to take NSAIDs
- •Use of postoperative DVT prophylaxis other than aspirin 81 mg twice daily
研究组 & 干预措施
Standard Opioid Prescription
Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription.
干预措施: Oxycodone 5 mg (Drug)
Opioid-Sparing Regimen
Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain.
干预措施: Placebo (Drug)
Opioid-Sparing Regimen
Participants receive a standardized multimodal non-opioid analgesic regimen throughout the perioperative period and are discharged with placebo tablets instead of a standard opioid prescription. All participants receive counseling from a Life Care Specialist and a limited supply of rescue hydromorphone for severe breakthrough pain.
干预措施: Multimodal Non-Opioid Analgesia (Other)
Standard Opioid Prescription
Participants receive the same standardized multimodal non-opioid analgesic regimen and Life Care Specialist counseling as the experimental group, but are discharged with a standard opioid prescription.
干预措施: Multimodal Non-Opioid Analgesia (Other)
结局指标
主要结局
Daily Pain Scores (Numeric Rating Scale, NRS)
时间窗: Postoperative Days 1-7
A 0-10 numeric scale used to assess pain intensity. Participants rate their pain three times daily during the first postoperative week. Mean daily pain scores will be compared between groups. High scores: greater pain intensity. Low scores: better pain control.
Opioid Consumption (Morphine Milligram Equivalents, MME)
时间窗: 1 week, 3 weeks, and 3 months postoperatively
Total opioid use, including study medication, rescue hydromorphone, and any additional prescriptions, will be converted to MME to quantify postoperative opioid consumption.
Pain-Related Contacts to Clinical Team
时间窗: Up to 3 months postoperatively
Number of calls or electronic messages to the surgical team related to pain management.
Medication-Related Side Effects
时间窗: Postoperative Days 1-7
Incidence and severity of nausea, constipation, vomiting, or other adverse effects associated with postoperative pain medications.
Opioid Prescription Refills
时间窗: Up to 3 months postoperatively
Number of opioid prescription refills requested or obtained after surgery.
Patient Satisfaction With Pain Control
时间窗: 1 week, 3 weeks, and 3 months
Patient-reported satisfaction with postoperative pain control, rated on a 5-point scale (much worse than expected to much better than expected).
次要结局
- Patient-Reported Outcomes (PROMs): HOOS Jr(Baseline (preoperative) and at 3 months)
- Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions)(Baseline (preoperative) and at 3 months)
- Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV)(Baseline (preoperative) and at 3 months)
- Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS)(Baseline (preoperative) and at 3 months)
- Postoperative Nausea (VAS-Nausea)(Postoperative Days 1-7)
- Sleep Quality and Pain-Related Satisfaction(Postoperative Days 1-7)
- Length of Stay (LOS)(Day of surgery through discharge (usually upto 7 days))
- Healthcare Utilization(Up to 3 months postoperatively)
研究者
Ajay Premkumar
Assistant Professor
Emory University