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.
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.
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.
Single group
Bupivacaine Liposome Injection
DrugBupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities).
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration.
Time to first rescue analgesia of opioid
Duration from administration to first use of opioid for rescue analgesia.
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
The proportion of patients who did not use rescue analgesia during 72 hours after administration.
The proportion of patients using patient-controlled intravenous analgesia (PCIA)
The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration.
Click on the lead sponsor to view all of their trials.
