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

StatusRecruiting
PhasePhase 4
Started2024-05-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Sep 28, 2026 → May 2027
See other at-risk trials from Jiangsu HengRui Medicine Co., Ltd.

Amendment history

2026-09-29
critical
Primary completion pushed: 2026-09-28 → 2027-05
Completion pushed: 2026-10-12 → 2027-05
2025-09-27
minor
2 amendments v2-v3
2 re-verifications since 2025-06-11, no change to tracked fields
2024-08-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-04-06→confirmed 2024-05-21
Study sitesdetails revised at 1 of 1 site
2024-03-27
minor
Original filing
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.
Trial Details
NCT Number NCT06344091
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Local Analgesia Via Infiltration
Enrollment 232 participants
Start Date 2024-05-21
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-28