Status:
NOT_YET_RECRUITING
A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Ankle (Ligaments); Instability (Old Injury)
Ankle Sprain
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 Noninferio...
Eligibility Criteria
Inclusion
- Age 18-65 years old. Scheduled for elective ankle arthroscopy under general anesthesia. American Society of Anesthesiologists (ASA) physical status I or II. Body mass index (BMI) 16-32 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.
Exclusion
- History of chronic pain (pain lasting \>3 months) or current use of opioid medications within the past 3 months.
- Known allergies or contraindications to study medications (celecoxib, acetaminophen, oxycodone, tramadol, dezocine).
- Severe cardiovascular, hepatic, renal, or respiratory dysfunction (ASA ≥ III). 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 may interfere with study participation or outcome assessment.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07154433
Start Date
September 1 2025
End Date
July 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310000