A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery
NCT ID: NCT07154433
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2025-09-01
2026-07-01
Brief Summary
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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\[email protected] This trial is registered to evaluate non-opioid alternatives for ankle arthroscopy pain control, prioritizing patient safety and evidence-based care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Randomization: Eligible participants (n = 110) are randomly assigned in a 1:1 ratio to either the non - opioid or opioid group using a computer - generated random number sequence. The randomization process is conducted by an independent statistician, ensuring unbiased allocation and minimizing selection bias.
Interventions:
Non - opioid group: Receives a multimodal non - opioid analgesic regimen, including celecoxib and acetaminophen, aiming to reduce opioid exposure and associated risks such as addiction, respiratory depression, and gastrointestinal adverse events.
Opioid group: Administered an opioid - based regimen with oxycodone - acetaminophen, representing the standard clinical practice for postoperative pain control.
Blinding: To prevent assessment b
PREVENTION
SINGLE
Investigators responsible for direct patient interactions, including administering medications, assessing pain scores (Numeric Rating Scale, NRS), recording adverse events, and evaluating patient - reported outcomes (such as PROMIS questionnaires), are unaware of the participants' assigned groups. This masking approach ensures that their evaluations remain objective and are not influenced by expectations regarding the effectiveness or safety of the intervention.
To maintain blinding integrity, study medications are packaged identically, and the label
Study Groups
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Non-Opioid Analgesia Group
Participants in this group will receive a multimodal non - opioid analgesic regimen. The treatment includes celecoxib(Flurbiprofen axetil) and acetaminophen(Jingxin (a Chinese pharmaceutical company)), aiming to provide effective pain relief while reducing the use of opioids and minimizing associated risks such as addiction, respiratory depression, and gastrointestinal adverse events during the perioperative period of ankle arthroscopy.
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).
Opioid Analgesia Group
This group will be administered an opioid - based regimen with oxycodone - acetaminophen(Parecoxib). It represents the standard clinical practice for postoperative pain control and serves as a reference to compare the efficacy and safety of the non - opioid regimen in managing pain after ankle arthroscopy.
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-0286
Identifier Type: -
Identifier Source: org_study_id
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