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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Pain score at 24 hours post-operation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-opioid analgesic regimen (Drug)
Opioid Analgesia Group
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.
干预措施: Opioid Analgesic Regimen (Drug)
结局指标
主要结局
Pain score at 24 hours post-operation
时间窗: 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.
次要结局
- 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)
- Pain score on the second postoperative day(2 hours post - operation; 2 - 6 days post - operation)
- Pain score on the third postoperative day(the third postoperative day)
- Pain score on the forth postoperative day(the forth postoperative day)
- Pain score on the fifth postoperative day(on the fifth postoperative day)
- Pain score on the sixth postoperative day(the sixth postoperative day)
- Insomnia Severity Index(Baseline (pre - operation), and 6 days post - operation)