Tegileridine for postoperative pain after adolescent scoliosis surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, non-inferiority trial compares Tegileridine with morphine for postoperative analgesia in adolescents undergoing posterior spinal fusion for scoliosis. Participants receive a loading dose followed by a patient-controlled analgesia pump, with three arms: Tegileridine 20 μg/kg loading dose plus 1 μg/kg per bolus, Tegileridine 20 μg/kg loading dose plus 2 μg/kg per bolus, and morphine 60 μg/kg loading dose plus 20 μg/kg per bolus. The study aims to determine if Tegileridine is not worse than morphine in the first 24–48 hours post-surgery and to compare adverse effects such as sedation and nausea. The trial is designed to assess both efficacy and safety in the adolescent population, with blinding maintained for participants and investigators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Not yet recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Not yet recruiting
• Beijing Chao-yang Hospital, Capital Medical University
  Beijing, China Not yet recruiting
• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, China Not yet recruiting
• Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University
  Shanghai, China Not yet recruiting

Study contacts

• Principal investigator: Ling Lan, Doctor — Peking Union Medical College Hospital
• Study coordinator: Juelun Wu, Doctor
• Email: pumchwujuelun@163.com
• Phone: +86 18707486338

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.