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A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients

A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients

Recruiting
6-17 years
All
Phase 4

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Overview

The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.

Eligibility

Inclusion Criteria:

  1. Subjects and guardians are willing to sign the informed consent.
  2. Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
  3. 6 years old ≤ age ≤17 years old , Male or female.
  4. ASA Physical Status Classification I-III.

Exclusion Criteria:

  1. Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days;
  2. Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days;
  3. Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate;
  4. Subjects with a history of chronic pain or visceral pain;
  5. Subjects with abnormal liver and kidney function;
  6. Subjects with clinically significant abnormal heart rate or rhythm;
  7. Subjects who are participating or planning to participate in any interventional clinical trial;
  8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Study details
    Local Analgesia Via Infiltration

NCT06344091

Jiangsu HengRui Medicine Co., Ltd.

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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