Scoliosis; AdolescencePhase 4NCT07229495
Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery
A Phase 4 study testing Tegileridine and morphine in people with Scoliosis; Adolescence and Pain After Surgery, run by Peking Union Medical College Hospital at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Scoliosis; Adolescence, Pain After Surgery, Analgesia, Patient-controlled
- What is being tested?
- Tegileridine and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 6 sitesChina
- Study dates
- 8 Apr 2026to 30 Dec 2027
- Phase
- Phase 4
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
- Severe cognitive impairment or uncontrolled psychiatric disorders (e.g., active schizophrenia) that preclude the patient's ability to comprehend the NRS or independently operate the patient-controlled analgesia (PCA) pump.
- 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 long-acting analgesics within 48 hours prior to surgery (short-acting non-opioid analgesics are permitted but must be discontinued at least 12 hours preoperatively).
- Planned postoperative admission to the intensive care unit (ICU).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ling Lan, Doctor contact
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Beijing Chao-yang Hospital, Capital Medical University
Beijing, 100020
Changwei Wei, Doctor, +86 13810678936, changwei.wei@ccmu.edu.cn
Changwei Wei, Doctor
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Juelun Wu, Doctor, +86 18707486338, pumchwujuelun@163.com
Ling Lan, Doctor
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaoping Zhu, Doctor, + 86 13907915506, 13907915506@163.com
Xiaoping Zhu, Doctor
- Not yet recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Yi Du, Doctor, +86 18101896668, duyi01@xinhuamed.com.cn
Lai Jiang, Doctor
- Not yet recruiting
Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
Hualin Chen, Doctor, +86 18930329981, 18930329981@163.com
Jijian Zheng, Doctor
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Mingzhu Cui, Doctor, +86 18639006993, Cuimingzhu78@163.com
Mingzhu Cui, Doctor
About this study
Official title: Efficacy and Safety of Tegileridine on Postoperative Pain in Adolescent Patients Undergoing Scoliosis Correction Surgery: A Multicentre, Double-blind, Non-inferiority, Randomised Controlled 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:
Read more
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.
Read the detailed description
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.
Group M (Active Comparator): Morphine 60 μg/kg loading dose, followed by PCA at a dose of 20 μg/kg per bolus.
The study medication will be prepared by an unblinded nurse not involved in subsequent patient care or assessment. Upon arrival in the post-anesthesia care unit (PACU) after surgery, the assigned loading dose of the study drug will be administered, immediately followed by the initiation of the PCA pump, which will be maintained for 48 hours. To maintain blinding, the study drugs are diluted in normal saline to appear identical. Patients, attending anesthesiologists, and outcome assessors will all be blinded to the treatment assignment.
The primary objective is to demonstrate the non-inferiority of Tegileridine to morphine in terms of analgesic efficacy. The primary efficacy endpoint is the area under the curve (AUC) of resting pain intensity scores, measured on an 11-point Numerical Rating Scale (NRS), over the first 24 hours after initiating PCA. A predefined non-inferiority margin of 12 will be used for the comparison. Statistical testing will follow a hierarchical procedure, first comparing the T2 group to the morphine group, and if non-inferiority is established, proceeding to compare the T1 group to morphine.
Secondary objectives include comparing the groups on various efficacy measures, such as pain AUC at other time points, rescue analgesic consumption, and patient satisfaction. Safety objectives focus on the incidence and severity of adverse events, with continuous monitoring for postoperative hypoxemia (SpO₂ < 90%), assessment of sedation levels using the modified Pasero Opioid-induced Sedation Scale (m-POSS), and recording of other common opioid-related side effects like postoperative nausea and vomiting (PONV).
The primary analysis will be conducted on the Full Analysis Set (FAS) and Per-Protocol Set (PPS). Sensitivity analyses and a pre-specified subgroup analysis by gender are also planned.
- Being tested
- Tegileridine, morphine
- Keywords
- Tegileridine, Postoperative Pain, Adolescent, Patient-Controlled Analgesia, Scoliosis
- Medical subject headings
- Scoliosis, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegileridineDrug
Tegileridine 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.
morphineDrug
Morphine 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.
| Study group | Role | What they receive |
|---|---|---|
| Tegileridine 20 μg/kg Loading Dose + 1 μg/kg PCA | Experimental | Participants in this arm will receive an initial intravenous loading dose of 20 μg/kg Tegileridine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting Tegileridine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 1 μg/kg Tegileridine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation. Receives: Drug: Tegileridine |
| Tegileridine 20 μg/kg Loading Dose + 2 μg/kg PCA | Experimental | Participants in this arm will receive an initial intravenous loading dose of 20 μg/kg Tegileridine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting Tegileridine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 2 μg/kg Tegileridine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation. Receives: Drug: Tegileridine |
| Morphine 60 μg/kg Loading Dose + 20 μg/kg PCA | Active comparator | Participants in this arm will receive an initial intravenous loading dose of 60 μg/kg morphine upon transfer to the post-anesthesia care unit (PACU), immediately followed by postoperative patient-controlled analgesia (PCA). The PCA solution is prepared by diluting morphine in normal saline to a total volume of 200 ml. The PCA pump is programmed to deliver a bolus dose of 20 μg/kg morphine per activation, with a 10-minute lockout interval and no background infusion. PCA therapy will be maintained for at least 48 hours, barring any adverse events requiring discontinuation. Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of the loading dose infusion up to 24 hours.
Secondary outcomes (15)
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.
Measured: 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.
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.
Measured: Assessed at 6, 12, 24, and 48 hours after the end of the loading dose infusion.
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.
Measured: Assessed at 16 predefined time points from 5 minutes to 48 hours after the end of the loading dose infusion.
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.
Measured: From the end of the loading dose infusion up to 48 hours.
Time to First Use of Rescue Analgesia
The time elapsed from the end of the loading dose infusion to the first administration of any rescue analgesic medication.
Measured: From the end of the loading dose infusion up to 48 hours (time to event is measured).
Total Number of Rescue Analgesic Administrations Per Participant
The total count of rescue analgesic medication administrations required for each participant during the PCA treatment period, when pain was not controlled (NRS ≥4) by the study drug.
Measured: From the end of the loading dose infusion up to 48 hours.
Cumulative Dose of Rescue Analgesic Medication
The total cumulative dose of all rescue analgesic medications used by each participant during the PCA treatment period. Doses of different opioids will be converted to morphine milligram equivalents (MME) for summation.
Measured: From the end of the loading dose infusion up to 48 hours.
Proportion of Participants with Pain NRS Score ≤ 3 at Each Assessment Time Point
The percentage of participants who achieve a pain intensity score of 3 or less (indicating mild pain) on the 11-point NRS 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.
Measured: Assessed at 16 predefined time points from 5 minutes to 48 hours after the end of the loading dose infusion.
Total Number of PCA Pump Attempts and Successful Deliveries
The total number of demands (attempts) made by the participant on the PCA pump and the total number of successful drug deliveries (effective deliveries) recorded by the pump during the treatment period.
Measured: From the end of the loading dose infusion up to 48 hours.
Postoperative Length of Hospital Stay
The duration of hospitalization after the surgical procedure, measured from the day of surgery until the day of discharge.
Measured: From the day of surgery to the day of hospital discharge, an average of 10 days.
Satisfaction with Pain Treatment
Participants' satisfaction with pain management is assessed using an 11-point numerical scale (0=extremely dissatisfied, 10=extremely satisfied) within 30 minutes after the cessation of PCA therapy.
Measured: At 30 minutes after stopping PCA (typically around 48 hours post-surgery).
Incidence of Postoperative Hypoxemia
The proportion of participants experiencing postoperative hypoxemia, defined as a percutaneous oxygen saturation (SpO2) reading below 90%, as monitored by pulse oximetry during the PCA treatment period.
Measured: From the end of the loading dose infusion up to 48 hours.
Incidence and Severity of Postoperative Nausea and Vomiting (PONV)
The occurrence and severity of PONV assessed by healthcare personnel using a Visual Analog Scale (VAS) for nausea/vomiting (0=no nausea/vomiting, 10=worst imaginable nausea/vomiting) at specified time points. Severity is categorized as mild (VAS<4cm), moderate (VAS 4-7cm), or severe (VAS>7cm).
Measured: Assessed at 5 minutes, 10 minutes, 30 minutes, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours after the end of the loading dose infusion.
Level of Sedation as Assessed by the Modified Pasero Opioid-Induced Sedation Scale (m-POSS)
The level of sedation is assessed by healthcare personnel using the m-POSS, which includes scores from S (sleep, easily aroused) to 4 (somnolent, minimal or no response to stimulus). Higher scores indicate deeper sedation.
Measured: Assessed at 5 minutes, 10 minutes, 30 minutes, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, and 48 hours after the end of the loading dose infusion.
Incidence of Other Adverse Events
The occurrence of other predefined adverse events during the treatment period, including abdominal pain, abdominal distension (time to first flatus and defecation), fever, dizziness, headache, sinus bradycardia, somnolence, and pruritus.
Measured: From the end of the loading dose infusion up to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start8 Apr 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Ling, Peking Union Medical College Hospital
- Investigators
- Ling Lan, Doctor, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229495
- Sponsor's protocol ID
- K7767
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD), alongside the study protocol, statistical analysis plan, and analytic code, will be available via a controlled-access process. Access will be granted to qualified researchers with methodologically sound proposals from 6 to 36 months following primary publication. Requesters must contact the corresponding author and sign a formal Data Access Agreement.