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

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country232 target enrollmentMay 21, 2024

ConditionsLocal Analgesia Via Infiltration

InterventionsBupivacaine Liposome Injection

DrugsBupivacaine Liposome Injection

Overview

Phase: Phase 4
Intervention: Bupivacaine Liposome Injection
Conditions: Local Analgesia Via Infiltration
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 232
Locations: 1
Primary Endpoint: The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 21, 2024

End Date

October 12, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

Bupivacaine Liposome Injection

Intervention: Bupivacaine Liposome Injection

Outcomes

Primary Outcomes

The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system

Time Frame: 0 minute to 14 days after administration

Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities)

Secondary Outcomes

Time to first rescue analgesia of opioid(0 minute to 72 hours after administration)
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(0 minute to 72 hours after administration)
Pain intensity score at rest after administration for children aged 6 to 7 years(0 minute to 72 hours after administration)
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years(0 minute to 72 hours after administration)
The proportion of patients using patient-controlled intravenous analgesia (PCIA)(0 minute to 72 hours after administration)
Pain intensity score at rest after administration for children aged 8 years and older(0 minute to 72 hours after administration)
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration(0 minute to 72 hours after administration)
Pain intensity score on movement (or cough) after administration for children aged 8 years and older(0 minute to 72 hours after administration)
Length of Stay(up to 2 weeks)