A Study on Reducing Opioid Use After Ankle Arthroscopy

Study Title Effect of a Postoperative Multimodal Analgesic Protocol Predominantly Based on Non-Opioid Medications vs Opioid-Based Analgesia on Pain After Ankle Arthroscopy: A Noninferiority Randomized Clinical Trial Purpose This study aims to compare the pain control effect and side effects of non-opioid versus opioid medications in patients undergoing ankle arthroscopy. The goal is to find a safer analgesic strategy to reduce opioid use and related risks (e.g., addiction, respiratory depression) while maintaining effective postoperative pain management. Design Study Type: Prospective, randomized controlled trial. Participants: 110 adults (18-65 years) scheduled for ankle arthroscopy under general anesthesia. Interventions: Experimental Group: Non-opioid regimen (celecoxib + acetaminophen). Control Group: Opioid regimen (oxycodone + acetaminophen). Assessments: Pain scores (NRS) at 2 hours,6 hours,12 hours, 24 hours, and days 2-6 postoperatively; Area under the curve (AUC\\\_{0-24}) of Numerical Rating Scale (NRS) pain intensity scores from 0-24 hours.adverse events (e.g., nausea, constipation); The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME); patient satisfaction. Key Eligibility Able to provide informed consent. ASA physical status I-II. BMI 16-32 kg/m². Exclusion criteria: Chronic pain, opioid use history, allergies to study drugs, or severe organ dysfunction. Benefits \& Risks Benefits: Standardized analgesia management and personalized pain monitoring; potential contribution to safer clinical pain protocols. Risks: Opioids may cause nausea, sedation, or respiratory depression; non-opioids may carry risks of gastrointestinal bleeding or liver injury. Emergency support is available for severe events. Contact Information For more details, contact the research team at Zhejiang University Second Affiliated Hospital: Phone: 0571-87783759 Email: keyanlunli\_zheer@163.com This trial is registered to evaluate non-opioid alternatives for ankle arthroscopy pain control, prioritizing patient safety and evidence-based care.

NCT Number	NCT07154433
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Ankle (Ligaments); Instability (Old Injury), Ankle Sprain, Talus Osteochondral Defect, Opioid Analgesia, Non-Opioid Pain Management
Enrollment	112 participants
Start Date	2025-09-01
Primary Completion	2026-05-01 (estimated)
Study Completion	2026-05-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-17