Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10-17
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 10 years to less than 18 years.
Scheduled to undergo posterior spinal fusion (PSF) surgery for adolescent idiopathic 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.
Disqualifiers
Baseline room-air oxygen saturation (SpO2) < 90% at rest, 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tegileridine
DrugTegileridine is a novel μ-opioid receptor-biased agonist. In this study, it is administered as an initial intravenous loading dose immediately followed by patient-controlled analgesia (PCA) for postoperative pain management. The PCA solution is prepared by diluting the Tegileridine injection in normal saline.
morphine
DrugMorphine is a standard opioid analgesic used as the active comparator in this study. It is administered as an initial intravenous loading dose immediately followed by patient-controlled analgesia (PCA) for postoperative pain management. The PCA solution is prepared by diluting Morphine injection in normal saline.
Treatment groups
171 Participants
are divided into 3 treatment groupsGroup A: Tegileridine 20 μg/kg Loading Dose + 1 μg/kg PCAExperimental treatment 1 intervention
Group B: Tegileridine 20 μg/kg Loading Dose + 2 μg/kg PCAExperimental treatment 1 intervention
Group C: Morphine 60 μg/kg Loading Dose + 20 μg/kg PCAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Curve (AUC) of Resting Pain Scores on the 11-point Numerical Rating Scale (NRS) Over the First 24 Hours Postoperative
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 the end of the loading dose infusion. 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.
Time frame
From the end of the loading dose infusion up to 24 hours.Secondary outcomes
1
Area Under the Curve (AUC) of Resting Pain Scores on the Numerical Rating Scale (NRS) Over Multiple Time Intervals
The AUC of resting pain intensity scores (measured on an 11-point NRS, where 0 represents "no pain" and 10 represents "the worst pain imaginable") will be calculated using the trapezoidal rule. The AUC will be calculated for the following cumulative time intervals after the end of the loading dose infusion: 0-6 hours, 0-12 hours, and 0-48 hours. A lower AUC indicates better and more sustained pain control over the specified period.
Time frame
The AUC will be calculated for the cumulative intervals from the end of the loading dose infusion up to 6 hours, 12 hours, and 48 hours.2
Area Under the Curve (AUC) of Activity-Induced Pain Scores on the Numerical Rating Scale (NRS) over Multiple Intervals
The AUC of pain intensity scores during activity (or coughing) measured on an 11-point NRS will be calculated over the intervals of 0-6 hours, 0-12 hours, 0-24 hours, and 0-48 hours after the end of the loading dose infusion. The AUC is calculated using the trapezoidal rule.
Time frame
Assessed at 6, 12, 24, and 48 hours after the end of the loading dose infusion.3
Resting and Activity-Induced Pain Scores on the Numerical Rating Scale (NRS) at Multiple Time Points
Pain intensity will be assessed using the 11-point NRS (0=no pain, 10=worst pain imaginable) at rest and during activity (or coughing) at the following time points after the end of the loading dose infusion: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, and 48 hours.
Time frame
Assessed at 16 predefined time points from 5 minutes to 48 hours after the end of the loading dose infusion.4
Proportion of Participants Requiring Rescue Analgesia
The percentage of participants who receive rescue analgesia during the PCA treatment period. Rescue analgesia is defined as the administration of additional analgesic medication (e.g., acetaminophen, NSAIDs, or other opioids) when the participant's pain is not adequately controlled (NRS score ≥4) despite receiving the study drug.
Time frame
From the end of the loading dose infusion up to 48 hours.Sponsors and contacts
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Source ClinicalTrials.gov