A Study on Reducing Opioid Use After Ankle Arthroscopy

Not Applicable

Not yet recruiting

• Conditions: Ankle (Ligaments); Instability (Old Injury); Ankle Sprain; Talus Osteochondral Defect; Opioid Analgesia; Non-Opioid Pain Management
• Interventions: Drug: Non-opioid analgesic regimen; Drug: Opioid Analgesic Regimen

• Registration Number: NCT07154433
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-10
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study Start: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Opioid Analgesia Group	Non-opioid analgesic regimen	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.
Opioid Analgesia Group	Opioid Analgesic Regimen	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.

Primary Outcome Measures

Name	Time	Method
Pain score at 24 hours post-operation	24 hours after ankle arthroscopy	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.

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC\_{0-24}) of Numerical Rating Scale (NRS) pain intensity scores from 0-24 hours.	Within 24 hours postoperatively	The area under the curve (AUC) of NRS pain scores within the first 24 hours will be calculated using NRS measurements at 2, 6, 12, and 24 hours postoperatively, providing an accurate estimate of the patient's overall pain experience during the 24-hour period.
The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME)	From immediately after surgery until 6 days post - operation	This indicator reflects whether pain control in the non-opioid group is adequate. If pain control is insufficient, patients will consume more opioids for rescue, thereby allowing an inference on the analgesic efficacy of the non-opioid regimen.
Incidence of adverse events	From the start of medication administration until 6 days post - operation	Adverse events related to the analgesic regimens will be recorded, including but not limited to nausea, vomiting, constipation, dizziness, sedation, respiratory depression, and gastrointestinal bleeding. The occurrence rate of each adverse event will be calculated for both groups to evaluate the safety profiles of the non - opioid and opioid interventions.
Patient - reported satisfaction	6 days post - operation	Participants will complete a 4-point likert scale to describe his satisfaction of the pain manegement at 6 days post - operation. The questionnaire assesses patients' overall satisfaction with the pain management strategy, including aspects such as effectiveness of pain relief, tolerability of medications, and impact on daily activities. Scores range from 1 (extremely dissatisfied) to 4 (extremely satisfied).
Patient - reported outcome measures (PROMIS) scores	Baseline (pre - operation), and 6 days post - operation	Participants will fill out the PROMIS Pain Interference - Short Form (PI - SF) . it evaluate the impact of pain on daily function , respectively. Scores are standardized, with higher values indicating greater interference or disturbance.
Pain score on the second postoperative day	2 hours post - operation; 2 - 6 days post - operation	Pain intensity will be evaluated using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain imaginable) at second postoperative day. the scores help to comprehensively assess the time - course of pain relief provided by each intervention.
Pain score on the third postoperative day	the third postoperative day	Pain intensity will be evaluated using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain imaginable) at third postoperative day. the scores help to comprehensively assess the time - course of pain relief provided by each intervention.
Pain score on the forth postoperative day	the forth postoperative day	Pain intensity will be evaluated using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain imaginable) at forth postoperative day. the scores help to comprehensively assess the time - course of pain relief provided by each intervention.
Pain score on the fifth postoperative day	on the fifth postoperative day	Pain intensity will be evaluated using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain imaginable) at fifth postoperative day. the scores help to comprehensively assess the time - course of pain relief provided by each intervention.
Pain score on the sixth postoperative day	the sixth postoperative day	Pain intensity will be evaluated using the Numeric Rating Scale (NRS, 0 = no pain, 10 = worst pain imaginable) at sixth postoperative day. the scores help to comprehensively assess the time - course of pain relief provided by each intervention.
Insomnia Severity Index	Baseline (pre - operation), and 6 days post - operation	To assess the subjective severity of insomnia before and after surgery, its impact on daytime functioning, and the degree of distress caused by sleep problems.

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China