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

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

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 Overview

• Status: Recruiting
• Conditions: Local Analgesia Via Infiltration
• Intervention / Treatment: Drug: Bupivacaine Liposome Injection

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thea Yu; Phone Number: +0518-82342973; Email: suyang.yu.sy17@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou Women and Children's Medical Center
      • Contact: Xingrong Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine Liposome Injection	Drug: Bupivacaine Liposome Injection; Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	0 minute to 72 hours after administration
Pain intensity score at rest after administration for children aged 8 years and older	Numercal Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).	0 minute to 72 hours after administration
Pain intensity score on movement (or cough) 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).	0 minute to 72 hours after administration
Pain intensity score on movement (or cough) after administration for children aged 8 years and older	Numercal Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes).	0 minute to 72 hours after administration
Length of Stay	The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.	up to 2 weeks

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): October 12, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: ZYWB-ZM-AHP-A-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No