NCT06344091 A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
| NCT ID | NCT06344091 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Local Analgesia Via Infiltration |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2026-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 232 participants in total. It began in 2024-05-21 with a primary completion date of 2026-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06344091 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Local Analgesia Via Infiltration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06344091 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06344091 currently recruiting?
Yes, NCT06344091 is actively recruiting participants. Contact the research team at suyang.yu.sy17@hengrui.com for enrollment information.
Where is the NCT06344091 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06344091 clinical trial?
NCT06344091 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 232 participants.