Not Yet RecruitingPhase 4

Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery

China171 participantsStarted 2026-07-01

Plain-language 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.

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing tegileridine specifically for pain after adolescent scoliosis surgery — is this medication something my surgeon has experience with, and how does it differ from the opioid or non-opioid pain management approach you'd normally use for this operation?
2Since this trial is Phase 4, does that mean tegileridine has already been approved and used in other settings, and what do we know so far about its safety profile in teenagers?
3The trial isn't recruiting yet — given that my child may need surgery soon, is the timeline realistic for us to even consider this study, or should we be planning around standard pain management instead?
4The study measures resting pain scores over the first 24 hours after surgery — does that mean the trial is mainly focused on immediate post-op pain, and how would my child's pain be managed after that 24-hour window if they're still hurting?
5Because this involves patient-controlled analgesia, how much responsibility would my child have for managing their own pain dosing during recovery, and is that realistic given their age and the stress of major spine surgery?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Curve (AUC) of Resting Pain Scores on the 11-point Numerical Rating Scale (NRS) Over the First 24 Hours Postoperative

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

Trial details

NCT IDNCT07229495

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Juelun Wu, Doctor

+86 18707486338 pumchwujuelun@163.com

View on ClinicalTrials.gov More Scoliosis; Adolescence trials