A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery

NCT07154433 | Recruiting

• 1 other identifier: 2025-0286
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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 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

Opioid Analgesia; Non-Opioid Pain Management; Ankle (Ligaments); Instability (Old Injury); Ankle Sprain; Talus Osteochondral Defect

Outcome Measures

Primary Outcomes (1)

• Pain score at 24 hours post-operation

  The pain score will be assessed using the Numeric Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." This score reflects the patient's subjective experience of pain intensity 24 hours after ankle arthroscopy. By comparing the NRS scores between the non - opioid analgesia group and the opioid analgesia group, we can evaluate the effectiveness of each intervention in managing acute postoperative pain.

  24 hours after ankle arthroscopy

Secondary Outcomes (11)

• Area under the curve (AUC\_{0-24}) of Numerical Rating Scale (NRS) pain intensity scores from 0-24 hours.

  Within 24 hours postoperatively

• The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME)

  From immediately after surgery until 6 days post - operation

• Incidence of adverse events

  From the start of medication administration until 6 days post - operation

• Patient - reported satisfaction

  6 days post - operation

• Patient - reported outcome measures (PROMIS) scores

  Baseline (pre - operation), and 6 days post - operation

Study Arms (2)

Non-Opioid Analgesia Group

EXPERIMENTAL

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.

Drug: Non-opioid analgesic regimen

Opioid Analgesia Group

ACTIVE COMPARATOR

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.

Drug: Opioid Analgesic Regimen

Interventions

Opioid Analgesic Regimen DRUG

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).

Opioid Analgesia Group

Non-opioid analgesic regimen DRUG

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).

Non-Opioid Analgesia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Zongyou Pan, Doctor

CONTACT

+ 86 19857004757; panzongyou@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: This study employs investigator masking (also known as single - blind) to minimize bias in data collection and assessment. Eligible participants undergoing ankle arthroscopy are randomly assigned to either the non - opioid or opioid analgesia group using a computer - generated random number sequence. The randomization process is managed by an independent statistician, who assigns participants to groups and stores this information securely. 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This interventional study employs a parallel - group, randomized, assessor - blinded design to compare the effectiveness and safety of non - opioid versus opioid medications for perioperative analgesia in ankle arthroscopy patients. 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

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-08

Locations

CN (1)