Status:
RECRUITING
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Local Analgesia Via Infiltration
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
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 Criteria
Inclusion Criteria:
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
- 6 years old ≤ age ≤17 years old , Male or female.
- ASA Physical Status Classification I-III.
Exclusion Criteria:
- Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days;
- Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days;
- Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate;
- Subjects with a history of chronic pain or visceral pain;
- Subjects with abnormal liver and kidney function;
- Subjects with clinically significant abnormal heart rate or rhythm;
- Subjects who are participating or planning to participate in any interventional clinical trial;
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 12 2026
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT06344091
Start Date
May 21 2024
End Date
October 12 2026
Last Update
October 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000