RecruitingPhase 4NCT06344091
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
232 participants
Start Date
May 21, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 6 YearsMax Age: 17 Years
Inclusion Criteria4
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
- years old ≤ age ≤17 years old , Male or female.
- ASA Physical Status Classification I-III.
Exclusion Criteria8
- 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.
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Interventions
DRUGBupivacaine Liposome Injection
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06344091