Using bupivacaine liposome injection for pain relief in children during orthopedic surgery
A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
This study is testing if a special pain relief injection can help children aged 6 to 17 feel better after orthopedic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06344091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6 to 17 years undergoing orthopedic surgery with a cumulative incision length of 3 cm or more.
Not a fit: Patients with a history of chronic pain, significant comorbidities, or those who have recently received similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management for children undergoing orthopedic procedures.
How similar studies have performed: Previous studies have shown promising results with liposomal formulations for pain management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Thea Yu
- Email: suyang.yu.sy17@hengrui.com
- Phone: +0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.