A Study on Reducing Opioid Use After Ankle Arthroscopy (NCT07154433) | Clinical Trial Compass
CompletedNot Applicable
A Study on Reducing Opioid Use After Ankle Arthroscopy
China112 participantsStarted 2025-09-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-65 years old. Scheduled for elective ankle arthroscopy under general anesthesia(Arthroscopic procedures including：(1) debridement procedures, including synovectomy, removal of loose bodies, and treatment of soft-tissue or bony impingement; (2) cartilage-related procedures, including debridement, microfracture, or other bone marrow stimulation techniques for osteochondral lesions of the talus; and (3) ligamentous procedures, including arthroscopically assisted repair or reconstruction for chronic lateral ankle instability).
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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at reducing opioid use after ankle arthroscopy for conditions like ligament instability or osteochondral defects of the talus — do you think the non-opioid pain management approach tested in this trial could apply to my specific situation?
2Since this trial is completed and measured pain scores at 24 hours after surgery, has the data been published yet, and can we look at those results together to understand how well non-opioid methods controlled pain in that critical first day?
3Given that this was a Phase NA study focused on pain management strategy rather than a new drug or device, how confident are you that the non-opioid approach it tested is safe and effective enough to consider for my recovery?
4If I were to undergo ankle arthroscopy, how would you personally plan to manage my post-operative pain, and does this trial's findings influence your approach at all?
5Are there patients with my specific ankle condition — whether it's a ligament instability issue or an osteochondral defect — for whom sticking with standard opioid pain management after surgery might actually be the safer or more appropriate choice?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain score at 24 hours post-operation
Timeframe: 24 hours after ankle arthroscopy
Trial details
NCT IDNCT07154433
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University