Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510000, China
Location status: Recruiting
Location contact
Xingrong Song
CONTACT
Recruiting
NCT Number: NCT06344091
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
6 year–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length≥3cm.
- 6 years old ≤ age ≤17 years old , Male or female.
- ASA Physical Status Classification I-III.
Exclusion criteria
- 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.
Treatment and study plan
Bupivacaine Liposome Injection
DrugBupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg)
Primary outcomes
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The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Time frame: 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 outcomes
-
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Time frame: 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.
-
Time to first rescue analgesia of opioid
Time frame: 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
Time frame: 0 minute to 72 hours after administration
The proportion of patients who did not use rescue analgesia during 72 hours after administration.
-
The proportion of patients using patient-controlled intravenous analgesia (PCIA)
Time frame: 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 6 to 7 years
Time frame: 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 at rest after administration for children aged 8 years and older
Time frame: 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).
-
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
Time frame: 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 8 years and older
Time frame: 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
Time frame: up to 2 weeks
The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Industry
Registry information
Official study title
A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 3, 2024
- Registry last updated
- Oct 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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