Using bupivacaine liposome injection for pain relief in children during orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of bupivacaine liposome injection for providing local analgesia in pediatric patients undergoing orthopedic surgery. The focus is on children aged 6 to 17 years who are expected to have a surgical incision of at least 3 cm. The study aims to assess how well this treatment works in a real-world clinical setting, particularly in managing postoperative pain. Participants will be monitored for any adverse effects and overall pain relief.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangzhou Women and Children's Medical Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Thea Yu
• Email: suyang.yu.sy17@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bupivacaine liposome injection for pain after single-port thoracoscopic lobectomy

  This test will try a long-acting bupivacaine liposome injection given as a paravertebral nerve block to reduce pain after single-port thoracoscopic lobectomy in adults.

  Recruiting Phase 2 Jiangsu HengRui Medicine Co., Ltd. · Shanghai, Shanghai Municipality · NCT06529432

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.