Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery

NCT07229495 | Not Yet Recruiting Phase 4

• 1 other identifier: K7767
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Scoliosis; Adolescence; Pain After Surgery; Analgesia, Patient-controlled

Keywords

Tegileridine; Postoperative Pain; Adolescent; Patient-Controlled Analgesia; Scoliosis

Outcome Measures

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 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.

  From the initiation of Patient-Controlled Analgesia (PCA) up to 24 hours post-initiation.

Secondary Outcomes (15)

• 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).

Study Arms (3)

Tegileridine 1 μg/kg PCA

EXPERIMENTAL

Participants in this arm will receive Tegileridine for postoperative patient-controlled analgesia (PCA). The intervention is administered as an intravenous infusion via a PCA pump. The PCA solution is prepared by diluting Tegileridine injection in normal saline to a total volume of 100 ml. The bolus dose is 1 μg/kg of Tegileridine per activation, with no background infusion. The lockout interval between bolus doses is 10 minutes. PCA therapy will be initiated in the post-anesthesia care unit (PACU) immediately after surgery and maintained for at least 48 hours, barring any PCA-related adverse events requiring discontinuation.

Drug: Tegileridine

Tegileridine 2 μg/kg PCA

EXPERIMENTAL

Participants in this arm will receive Tegileridine for postoperative patient-controlled analgesia (PCA). The intervention is administered as an intravenous infusion via a PCA pump. The PCA solution is prepared by diluting Tegileridine injection in normal saline to a total volume of 100 ml. The bolus dose is 2 μg/kg of Tegileridine per activation, with no background infusion. The lockout interval between bolus doses is 10 minutes. PCA therapy will be initiated in the post-anesthesia care unit (PACU) immediately after surgery and maintained for at least 48 hours, barring any PCA-related adverse events requiring discontinuation.

Drug: Tegileridine

Morphine 20 μg/kg PCA

ACTIVE COMPARATOR

Participants in this arm will receive Morphine for postoperative patient-controlled analgesia (PCA). This arm serves as the active comparator. The intervention is administered as an intravenous infusion via a PCA pump. The PCA solution is prepared by diluting Morphine injection in normal saline to a total volume of 100 ml. The bolus dose is 20 μg/kg of Morphine per activation, with no background infusion. The lockout interval between bolus doses is 10 minutes. PCA therapy will be initiated in the post-anesthesia care unit (PACU) immediately after surgery and maintained for at least 48 hours, barring any PCA-related adverse events requiring discontinuation.

Drug: morphine

Interventions

Tegileridine DRUG

Tegileridine is an investigational novel opioid receptor agonist. In this study, it is administered as an intravenous infusion via a patient-controlled analgesia (PCA) pump for postoperative pain management. The PCA solution is prepared by diluting Tegileridine injection in normal saline.

Tegileridine 1 μg/kg PCA; Tegileridine 2 μg/kg PCA

morphine DRUG

Morphine is a standard opioid analgesic used as the active comparator in this study. It is administered as an intravenous infusion via a patient-controlled analgesia (PCA) pump for postoperative pain management. The PCA solution is prepared by diluting Morphine injection in normal saline.

Morphine 20 μg/kg PCA

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Scoliosis; Agnosia; Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ling Lan, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juelun Wu, Doctor

CONTACT

+86 18707486338; pumchwujuelun@163.com

Ling Lan, Doctor

CONTACT

+86 18612672275

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)