Efficacy and Safety of Tegileridine for Postoperative Analgesia Following Adolescent Scoliosis Correction Surgery: A Prospective, Multicentre, Double-Blind, Non-Inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 171
- 试验地点
- 7
- 主要终点
- Area Under the Curve (AUC) of Resting Pain Scores on the 11-point Numerical Rating Scale (NRS) Over the First 24 Hours Postoperative
研究概览
简要总结
The goal of this clinical trial is to see if a new pain medicine called Tegileridine is at least as effective as morphine (the standard treatment) for pain relief after spinal surgery in teenagers with scoliosis. This type of study is called a "non-inferiority" trial. The study will also carefully compare the safety of both medicines.
The main questions it aims to answer are:
Is Tegileridine no worse than morphine at controlling pain in the first 24 hours after surgery? How do the side effects (like sleepiness or nausea) of Tegileridine compare to those of morphine? Researchers will compare two different doses of Tegileridine against morphine. Neither the participants nor the doctors assessing them will know which medicine is being given.
Participants in this study will:
Receive one of the three pain medicine options through a pump (called a PCA pump) that they can control themselves after surgery.
Use the pump for up to 48 hours. Regularly rate their pain levels using a simple number scale. Have their health closely monitored by the study team during this time.
详细描述
This is a prospective, multicentre, randomized, double-blind, controlled, non-inferiority clinical trial designed to evaluate the efficacy and safety of Tegileridine for postoperative analgesia in adolescent patients undergoing spinal fusion surgery for scoliosis.
Postoperative pain management is crucial for recovery, with opioids like morphine being the standard of care. However, morphine is associated with significant side effects, including respiratory depression, nausea, and vomiting. Tegileridine is a novel, highly selective μ-opioid receptor agonist that is hypothesized to provide potent analgesia with an improved safety profile, particularly regarding respiratory depression.
A total of 171 adolescent patients (aged 10 to <18 years) scheduled for surgery will be enrolled. Participants will be randomly assigned in a 1:1:1 ratio to one of three treatment groups:
Group T1: Tegileridine 20 μg/kg loading dose, followed by patient-controlled analgesia (PCA) at a dose of 1 μg/kg per bolus.
Group T2: Tegileridine 20 μg/kg loading dose, followed by PCA at a dose of 2 μg/kg per bolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 10 years to less than 18 years.
- •Scheduled to undergo posterior spinal fusion (PSF) surgery for scoliosis under general anesthesia.
- •American Society of Anesthesiologists (ASA) physical status classification I to III.
- •The participant and their parent or legal guardian voluntarily provide written informed consent prior to any study-related procedures.
排除标准
- •History of difficult airway, severe respiratory depression (SpO₂ < 90%), acute or severe bronchial asthma.
- •History of severe cardiovascular or cerebrovascular disease, such as myocardial infarction, unstable angina, second-degree or higher atrioventricular block, NYHA Class III or higher heart failure, or stroke.
- •Known or suspected gastrointestinal obstruction, including paralytic ileus.
- •Known hypersensitivity to opioids or any component of the study drug formulation.
- •History of psychiatric disorders (e.g., schizophrenia, depression) or cognitive impairment.
- •Diagnosis of neuromuscular scoliosis or presence of any other chronic pain condition that may interfere with postoperative pain assessment.
- •Chronic use of opioid analgesics or use of any analgesic medication within 48 hours prior to surgery.
- •Planned postoperative admission to the intensive care unit (ICU).
- •Any other condition deemed by the investigator to be inappropriate for participation in the study.
结局指标
主要结局
Area Under the Curve (AUC) of Resting Pain Scores on the 11-point Numerical Rating Scale (NRS) Over the First 24 Hours Postoperative
时间窗: From the initiation of Patient-Controlled Analgesia (PCA) up to 24 hours post-initiation.
The analgesic efficacy will be assessed by calculating the Area Under the Curve (AUC) of the resting pain intensity scores over the first 24 hours after initiating Patient-Controlled Analgesia (PCA). Pain Intensity Measurement: Pain intensity is assessed by the participant using an 11-point Numerical Rating Scale (NRS), where 0 represents "no pain" and 10 represents "the worst pain imaginable." Resting state is defined as being in a stationary position without active movement. Assessment Time Points: NRS scores are recorded at predefined time points: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, and 24 hours after PCA initiation. AUC Calculation: The AUC for the NRS scores versus time is calculated using the trapezoidal rule, which sums the areas of trapezoids formed between consecutive time points. A lower AUC indicates better and more sustained pain control over the 24-hour period.
次要结局
- Total Number of Rescue Analgesic Administrations Per Participant(From PCA initiation up to 48 hours post-initiation.)
- Area Under the Curve (AUC) of Resting Pain Scores on the Numerical Rating Scale (NRS) Over Multiple Time Intervals(The AUC will be calculated for the cumulative intervals from PCA initiation up to 6 hours, 12 hours, and 48 hours post-initiation.)
- Area Under the Curve (AUC) of Activity-Induced Pain Scores on the Numerical Rating Scale (NRS) over Multiple Intervals(Assessed at 6, 12, 24, and 48 hours after PCA initiation.)
- Resting and Activity-Induced Pain Scores on the Numerical Rating Scale (NRS) at Multiple Time Points(Assessed at 16 predefined time points from 5 minutes to 48 hours after PCA initiation.)
- Proportion of Participants Requiring Rescue Analgesia(From PCA initiation up to 48 hours post-initiation.)
- Time to First Use of Rescue Analgesia(From PCA initiation up to 48 hours post-initiation (time to event is measured).)
- Cumulative Dose of Rescue Analgesic Medication(From PCA initiation up to 48 hours post-initiation.)
- Proportion of Participants with Pain NRS Score ≤ 3 at Each Assessment Time Point(Assessed at 16 predefined time points from 5 minutes to 48 hours after PCA initiation.)
- Total Number of PCA Pump Attempts and Successful Deliveries(From PCA initiation up to 48 hours post-initiation.)
- Postoperative Length of Hospital Stay(From the day of surgery to the day of hospital discharge, an average of 10 days.)
- Satisfaction with Pain Treatment(At 30 minutes after stopping PCA (typically around 48 hours post-surgery).)
- Incidence of Postoperative Hypoxemia(From PCA initiation up to 48 hours post-initiation.)
- Incidence and Severity of Postoperative Nausea and Vomiting (PONV)(Assessed at 5 minutes, 10 minutes, 30 minutes, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours after PCA initiation.)
- Level of Sedation as Assessed by the Modified Pasero Opioid-Induced Sedation Scale (m-POSS)(Assessed at 5 minutes, 10 minutes, 30 minutes, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours after PCA initiation.)
- Incidence of Other Adverse Events(From PCA initiation up to 48 hours post-initiation.)
研究者
Lan Ling
Principal Investigator
Peking Union Medical College Hospital