Actively Recruiting
A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-06
110
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 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.
CONDITIONS
Official Title
A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- Scheduled for elective ankle arthroscopy under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Body mass index (BMI) between 16 and 32 kg/m²
- Able to understand and sign the informed consent form
- Willing and able to comply with study procedures including follow-up visits and outcome assessments
You will not qualify if you...
- History of chronic pain lasting more than 3 months or opioid use within the past 3 months
- Allergies or contraindications to celecoxib, acetaminophen, oxycodone, tramadol, or dezocine
- Severe cardiovascular, liver, kidney, or lung dysfunction (ASA III or higher)
- History of substance abuse, alcohol dependence, or significant psychiatric disorders
- Pregnant or breastfeeding women
- Participation in another clinical trial within the past 30 days
- Unstable medical conditions that could interfere with study participation or outcome assessments
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Z
Zongyou Pan, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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