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
- Local Analgesia Via Infiltration
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrolment target
- 232
- Started
- 21 May 2024
- Main results due
- May 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 6 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(1)
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06344091. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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