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

NCT06344091 | Recruiting Phase 4

• 1 other identifier: ZYWB-ZM-AHP-A-003
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  0 minute to 14 days after administration

Secondary Outcomes (9)

• 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

• 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

• 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 6 to 7 years

  0 minute to 72 hours after administration

Study Arms (1)

Bupivacaine Liposome Injection

EXPERIMENTAL

Drug: Bupivacaine Liposome Injection

Interventions

Bupivacaine Liposome Injection DRUG

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

Bupivacaine Liposome Injection

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects and guardians are willing to sign the informed consent.
• Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
• years old ≤ age ≤17 years old , Male or female.
• ASA Physical Status Classification I-III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Thea Yu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm study of liposomal bupivacaine injection

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 3, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-06

Locations

CN (1)