A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery

ZYWB-ZM-AHP-A-003

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.

2024-04-06

2026-09-28

2026-10-12

Not yet recruiting

Early phase I

232

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-arm study of liposomal bupivacaine injection', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 232, 'type': 'ESTIMATED'}}

2024-04-03