Clinical trial NCT06344091: A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Official title: A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Local Analgesia Via Infiltration
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 232
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm study of liposomal bupivacaine injection
Primary purpose: PREVENTION

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:

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.

Primary outcomes:
measure: The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
timeFrame: 0 minute to 14 days after administration
Secondary outcomes:
measure: The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
timeFrame: 0 minute to 72 hours after administration
measure: Time to first rescue analgesia of opioid
timeFrame: 0 minute to 72 hours after administration
measure: The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
timeFrame: 0 minute to 72 hours after administration
measure: The proportion of patients using patient-controlled intravenous analgesia (PCIA)
timeFrame: 0 minute to 72 hours after administration
measure: Pain intensity score at rest after administration for children aged 6 to 7 years
timeFrame: 0 minute to 72 hours after administration
measure: Pain intensity score at rest after administration for children aged 8 years and older
timeFrame: 0 minute to 72 hours after administration
measure: Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
timeFrame: 0 minute to 72 hours after administration
measure: Pain intensity score on movement (or cough) after administration for children aged 8 years and older
timeFrame: 0 minute to 72 hours after administration
measure: Length of Stay
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
References: