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

NCT ID: NCT06344091

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2026-10-12

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.

Conditions

Local Analgesia Via Infiltration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bupivacaine Liposome Injection

Group Type: EXPERIMENTAL

Bupivacaine Liposome Injection

Intervention Type: DRUG

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

Interventions

Bupivacaine Liposome Injection

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Thea Yu

Role: CONTACT

suyang.yu.sy17@hengrui.com

+0518-82342973

Facility Contacts

Xingrong Song

Role: primary

Other Identifiers

ZYWB-ZM-AHP-A-003

Identifier Type: -

Identifier Source: org_study_id