Clinical Trial

Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block

Completed Phase 2
View on ClinicalTrials.gov →
Summary
This prospective, sequential dose-finding clinical observational study aims to estimate the median effective concentration (EC50) and the 95% effective concentration (EC95) of liposomal bupivacaine for ultrasound-guided femoral nerve block. Sensory and motor block endpoints are evaluated separately at 30 minutes after block placement using a modified up-and-down (sequential allocation) design, with trial termination after eight reversal points.
Protocol Amendment History 4 changes
critical Trial status changed: Not Yet Recruiting → Completed 2026-05-15
notable Enrollment increased: 60 -> 79 participants 2026-05-15
notable Primary completion pushed: 2026-03 -> 2026-03-31 2026-05-15
minor Completion pushed: 2026-03 -> 2026-04-01 2026-05-15
Trial Details
NCT Number NCT07366905
Lead Sponsor Hainan Medical College
Collaborators: The Second Affiliated Hospital of Hainan Medical University
Conditions Patients Eligible for Elective Lower Extremity Femoral Nerve Surgery, Knee Arthroscopic Surgery
Enrollment 79 participants
Start Date 2026-02-01
Primary Completion 2026-03-31 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14