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

Phase 4

Recruiting

• Conditions: Local Analgesia Via Infiltration
• Interventions: Drug: Bupivacaine Liposome Injection

• Registration Number: NCT06344091
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-27
• Study First Posted: 2024-04-03
• Study Start: 2024-05-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-09-28
• Study Completion: 2026-10-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bupivacaine Liposome Injection	Bupivacaine Liposome Injection	-

Primary Outcome Measures

Name	Time	Method
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system	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 Outcome Measures

Name	Time	Method
Time to first rescue analgesia of opioid	0 minute to 72 hours after administration	Duration from administration to first use of opioid for rescue analgesia.
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 who did not use rescue analgesia during 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	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).
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years	0 minute to 72 hours after administration	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).
The proportion of patients using patient-controlled intravenous analgesia (PCIA)	0 minute to 72 hours after administration	The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration.
Pain intensity score at rest after administration for children aged 8 years and older	0 minute to 72 hours after administration	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).
Length of Stay	up to 2 weeks	The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.
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	Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 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	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).

Trial Locations

Locations (1)

Guangzhou Women and Children's Medical Center; 🇨🇳 Guangzhou, Guangdong, China