Ankle (Ligaments); Instability (Old Injury)NCT07154433
A Study on Reducing Opioid Use After Ankle Arthroscopy
A study testing Opioid Analgesic Regimen and Non-opioid analgesic regimen in people with Ankle (Ligaments); Instability (Old Injury) and Ankle Sprain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle (Ligaments); Instability (Old Injury), Ankle Sprain, Talus Osteochondral Defect
- What is being tested?
- Opioid Analgesic Regimen and Non-opioid analgesic regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 7 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
About this study
Official 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
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.
Read more
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.
- Conditions
- Ankle (Ligaments); Instability (Old Injury), Ankle Sprain, Talus Osteochondral Defect, Opioid Analgesia, Non-Opioid Pain Management
- Being tested
- Opioid Analgesic Regimen, Non-opioid analgesic regimen
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Analgesic RegimenDrug
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 regimenDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 usual 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. Receives: Drug: Opioid Analgesic Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Within 24 hours postoperatively
The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME)
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.
Measured: From immediately after surgery until 6 days post - operation
Incidence of adverse events
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.
Measured: From the start of medication administration until 6 days post - operation
Patient - reported satisfaction
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).
Measured: 6 days post - operation
Patient - reported outcome measures (PROMIS) scores
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.
Measured: Baseline (pre - operation), and 6 days post - operation
Pain score on the second postoperative day
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.
Measured: 2 hours post - operation; 2 - 6 days post - operation
Pain score on 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.
Measured: the third postoperative day
Pain score on 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.
Measured: the forth postoperative day
Pain score 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.
Measured: on the fifth postoperative day
Pain score on 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.
Measured: the sixth postoperative day
Insomnia Severity Index
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.
Measured: Baseline (pre - operation), and 6 days post - operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025
- Primary completion1 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle (Ligaments); Instability (Old Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 is stratified by the surgical incision: standard arthroscopic portals versus the arthroscopy-assisted mini-open approach. The randomization process is conducted by an independent statistician, ensuring unbiased allocation and minimizing selection bias.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154433
- Sponsor's protocol ID
- 2025-0286
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07154433
- Acronym / sponsor ID
- 2025-0286
- Conditions
- Ankle (Ligaments); Instability (Old Injury), Ankle Sprain, Talus Osteochondral Defect, Opioid Analgesia, Non-Opioid Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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 is stratified by the surgical incision: standard arthroscopic portals versus the arthroscopy-assisted mini-open approach. The randomization process is conducted by an independent statistician, ensuring unbiased allocation and minimizing selection bias.
| Arm | Type | Receives |
|---|---|---|
| Non-Opioid Analgesia Group | Experimental | Drug: Non-opioid analgesic regimenParticipants 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 | Active comparator | Drug: Opioid Analgesic RegimenThis group will be administered an opioid - based regimen with oxycodone - acetaminophen(Parecoxib). It represents the usual 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Analgesic RegimenParticipants 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). | Drug | Opioid Analgesia Group |
| Non-opioid analgesic regimenImmediately 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). | Drug | Non-Opioid Analgesia Group |
Primary outcome
Pain score at 24 hours post-operation
Time frame: 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.
11 secondary outcomes
Area under the curve (AUC_{0-24}) of Numerical Rating Scale (NRS) pain intensity scores from 0-24 hours.
Time frame: Within 24 hours postoperatively
The total consumption of additional rescue opioids, expressed as oral morphine equivalent dose (OME)
Time frame: From immediately after surgery until 6 days post - operation
Incidence of adverse events
Time frame: From the start of medication administration until 6 days post - operation
Patient - reported satisfaction
Time frame: 6 days post - operation
Patient - reported outcome measures (PROMIS) scores
Time frame: Baseline (pre - operation), and 6 days post - operation
Pain score on the second postoperative day
Time frame: 2 hours post - operation; 2 - 6 days post - operation
Pain score on the third postoperative day
Time frame: the third postoperative day
Pain score on the forth postoperative day
Time frame: the forth postoperative day
Pain score on the fifth postoperative day
Time frame: on the fifth postoperative day
Pain score on the sixth postoperative day
Time frame: the sixth postoperative day
Insomnia Severity Index
Time frame: Baseline (pre - operation), and 6 days post - operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Analgesic Regimen and Non-opioid analgesic regimen in people with Ankle (Ligaments); Instability (Old Injury) and Ankle Sprain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score at 24 hours post-operation (time frame: 24 hours after ankle arthroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.