A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients

Phase 4RecruitingNCT06344091

Jiangsu HengRui Medicine Co., Ltd.232 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

232

Conditions

Local Analgesia Via Infiltration

Interventions

Bupivacaine Liposome InjectionDRUG

Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 0 minute to 14 days after administration

Secondary Outcomes

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 frame: 0 minute to 72 hours after administration

Time to first rescue analgesia of opioid

Duration from administration to first use of opioid for rescue analgesia.

Time frame: 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

The proportion of patients who did not use rescue analgesia during 72 hours after administration.

Time frame: 0 minute to 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.

Time frame: 0 minute to 72 hours after administration

Pain intensity score at rest after administration for children aged 6 to 7 years

Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).

Central Contacts

Thea Yu

CONTACT

+0518-82342973 suyang.yu.sy17@hengrui.com

Data from ClinicalTrials.gov

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