Opioid-Sparing Joint Replacement

Официальное название

Opioid-Sparing Joint Replacement - Single Site Randomized Control Trial

Обзор

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?

Подробное описание

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.

Вмешательства

• Препарат Placebo
  * 28 tablets identical in appearance to 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Dispensed by Investigational Drug Services * Used in combination with standardized multimodal analgesia
• Препарат Oxycodone 5 mg
  * 28 tablets of 5-mg oxycodone * Taken 1-2 tablets every 4 hours as needed for moderate to severe pain * Represents standard postoperative prescribing practi
• Другое Multimodal Non-Opioid Analgesia
  Multimodal Non-Opioid Analgesia (Standardized Regimen) Includes: * Acetaminophen * Meloxicam * Methylprednisolone taper * Spinal anesthesia * Periarticular local anesthetic injection * Postoperative scheduled acetaminophen and NSAIDs * Counseling by Life Care Specialist * Two 2-mg hydromorphone tablets for rescue only

Первичные конечные точки

• Daily Pain Scores (Numeric Rating Scale, NRS) [Срок оценки: Postoperative Days 1-7]
• Opioid Consumption (Morphine Milligram Equivalents, MME) [Срок оценки: 1 week, 3 weeks, and 3 months postoperatively]
• Pain-Related Contacts to Clinical Team [Срок оценки: Up to 3 months postoperatively]
• Medication-Related Side Effects [Срок оценки: Postoperative Days 1-7]
• Opioid Prescription Refills [Срок оценки: Up to 3 months postoperatively]
• Patient Satisfaction With Pain Control [Срок оценки: 1 week, 3 weeks, and 3 months]

Вторичные конечные точки (8)

• Patient-Reported Outcomes (PROMs): HOOS Jr [Срок оценки: Baseline (preoperative) and at 3 months]
• Patient-Reported Outcomes (PROMs): EQ-5D (EuroQol-5 Dimensions) [Срок оценки: Baseline (preoperative) and at 3 months]
• Patient-Reported Outcomes (PROMs): Subjective Hip Value (SHV) [Срок оценки: Baseline (preoperative) and at 3 months]
• Patient-Reported Outcomes (PROMs): Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline (preoperative) and at 3 months]
• Postoperative Nausea (VAS-Nausea) [Срок оценки: Postoperative Days 1-7]
• Sleep Quality and Pain-Related Satisfaction [Срок оценки: Postoperative Days 1-7]
• Length of Stay (LOS) [Срок оценки: Day of surgery through discharge (usually upto 7 days)]
• Healthcare Utilization [Срок оценки: Up to 3 months postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Diabetes mellitus with HbA1c > 8.0%
• Diagnosis of chronic pain syndrome or fibromyalgia
• Pain Catastrophizing Scale (PCS) score > 29
• Any condition that, in the investigator's judgment, may interfere with adherence to study procedures or follow-up

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Emory University Orthopedics and Spine Hospital — Atlanta

Идентификаторы

NCT: NCT07348627 · 2025P011932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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