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Tegileridine for Postoperative Pain After Adolescent Scoliosis Surgery

NCT07229495 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-06-17

No results posted yet for this study

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

Interventions

DRUG

Tegileridine

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.

DRUG

morphine

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Ling Lan, Doctor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229495 on ClinicalTrials.gov