NCT07154433

A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery

Effect of a Postoperative Multimodal Analgesic Protocol Predominantly Based on Non-Opioid Medications vs Opioid-Based Analgesia on Pain After Minimally Invasive Ankle Surgery: A Noninferiority Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Study Title Effect of a Postoperative Multimodal Analgesic Protocol Predominantly Based on Non-Opioid Medications vs Opioid-Based Analgesia on Pain After Minimally Invasive Ankle Surgery: 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 and Mini-open ankle surgery 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: [phone] Email: keyanlunli\[e-mail] This trial is registered to evaluate non-opioid alternatives for ankle arthroscopy pain control, prioritizing patient safety and evidence-based care.

Conditions

• Ankle (Ligaments); Instability (Old Injury)
• Ankle Sprain
• Talus Osteochondral Defect
• Opioid Analgesia
• Non-Opioid Pain Management

Interventions

Type	Name	Description
DRUG	Opioid Analgesic Regimen	Participants will take 5 mg/325 mg of oxycodone - acetaminophen every 6 hours as needed for pain, with a maximum of 4 doses per day. Rescue analgesia protocol: a limited rescue prescription of oxycodone/acetaminophen (containing 5 mg oxycodone), to be taken every 2 hours as needed, with no more than 10 tablets per day, and only if adequate pain relief is not achieved (defined as NRS score ≥ 4).
DRUG	Non-opioid analgesic regimen	Immediately after surgery, patients will receive oral acetaminophen 500 mg plus celecoxib 400 mg. Thereafter, celecoxib 200 mg BID and acetaminophen 500 mg Q6H will be administered. Rescue analgesia protocol: a limited rescue prescription of oxycodone/acetaminophen (containing 5 mg oxycodone), to be taken every 2 hours as needed, with no more than 10 tablets per day, and only if adequate pain relief is not achieved (defined as NRS score ≥ 4).

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-09-04
• Last updated: 2026-03-06

Locations

1 site across 1 country: China