RecruitingPhase 4

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

China232 participantsStarted 2024-05-21

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system

Timeframe: 0 minute to 14 days after administration

Trial details

NCT IDNCT06344091

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-28

Contact for this trial

Thea Yu

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

View on ClinicalTrials.gov More Local Analgesia Via Infiltration trials