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
This will see if a non-opioid pain plan (celecoxib plus acetaminophen) controls pain as well as an opioid plan (oxycodone plus acetaminophen) in adults having minimally invasive ankle surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07154433 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized noninferiority trial enrolling 110 adults aged 18–65 undergoing elective ankle arthroscopy or mini-open ankle surgery under general anesthesia. Participants are randomized to a multimodal non-opioid regimen (celecoxib + acetaminophen) or an opioid-based regimen (oxycodone + acetaminophen). Pain intensity (NRS) is recorded at 2, 6, 12, and 24 hours and on postoperative days 2–6, and adverse effects and opioid consumption are tracked. The primary aim is to determine whether the non-opioid protocol provides comparable pain control while reducing opioid exposure and related risks.
Who should consider this trial
Good fit: Adults 18–65 scheduled for elective ankle arthroscopy or mini-open ankle surgery under general anesthesia with ASA I–II, BMI 16–32, who are not chronic opioid users and can provide informed consent.
Not a fit: Patients with chronic pain or recent opioid use, severe organ dysfunction (ASA ≥III), allergies to the study drugs, pregnancy or breastfeeding, or active substance abuse are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, patients could get similar pain relief with fewer opioid prescriptions and lower risk of opioid-related side effects and dependence.
How similar studies have performed: Multimodal non-opioid pain protocols have shown comparable pain control to opioid regimens in some orthopedic procedures, but data specifically for minimally invasive ankle surgery are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.
Where this trial is running
Hangzhou, Zhejiang
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Zongyou Pan, Doctor
- Email: panzongyou@zju.edu.cn
- Phone: + 86 19857004757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.