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RECRUITING Phase 4 ClinicalTrials.gov

Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery

Sponsor: Peking Union Medical College Hospital • ClinicalTrials.gov ID: NCT07229495

Registry updated: 2026-10-13
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Description

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.

Interventions

  • Tegileridine (Drug)
    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.
  • morphine (Drug)
    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.

Eligibility criteria

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).

Conditions

Scoliosis; Adolescence Pain After Surgery Analgesia, Patient-controlled

Locations

  • Henan Provincial People's Hospital — Zhengzhou, Henan, China
  • The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • Beijing Chao-yang Hospital, Capital Medical University — Beijing, China
  • Peking Union Medical College Hospital — Beijing, China
  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China
  • Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University — Shanghai, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record