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

RecruitingPhase 4Ages 6 Years - 17 YearsAllJiangsu HengRui Medicine Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 3cm. 3. 6 years old โ‰ค age โ‰ค 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.
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What it tests

  • Bupivacaine Liposome Injection
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Where

1 site
Guangzhou Women and Children's Medical Center
Guangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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