Trial intelligence / Profile preview

Liposomal Bupivacaine for Femoral Nerve Block

NCT07366905Phase 2

Key facts

Status: Completed
Start: Feb 2026
Primary completion: Mar 2026
Countries: 1
Sponsor: Hainan Medical University
Modality: Small Molecules

Drugs: liposomal bupivacaine
Conditions: Anesthesia

Overview

Phase 2, open-label, single-arm trial of liposomal bupivacaine in Anesthesia, sponsored by Hainan Medical University. Primary endpoints: Median effective concentration (EC50) and 95% effective concentration (EC95) for femoral nerve sensory block at 30 minutes and Median effective concentration (EC50) and 95% effective concentration (EC95) for femoral nerve motor block at 30 minutes. Started Feb 2026; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Ultrasound-guided femoral nerve block with liposomal bupivacaine
Participants receive ultrasound-guided femoral nerve block with liposomal bupivacaine administered at varying concentrations using a modified up-and-down sequential dose-finding design.

Who it enrols

Adults aged 18-85 scheduled for elective unilateral lower limb surgery requiring a femoral nerve block, excluding those with allergies to amide-type local anesthetics, infection at the injection site, coagulopathy, pre-existing neurological deficits, severe hepatic dysfunction, or who are pregnant/breastfeeding.

Endpoints

Primary

Median effective concentration (EC50) and 95% effective concentration (EC95) for femoral nerve sensory block30 minutes
Median effective concentration (EC50) and 95% effective concentration (EC95) for femoral nerve motor block30 minutes

Secondary

Postoperative Resting pain intensity assessed by VASDay 2
Postoperative movement-evoked pain assessed by VASDay 2
Quadriceps muscle strength after surgeryDay 2
Length of hospital stayUp to 30 days
Time to first ambulation after surgeryUp to 72 hours
Intraoperative heart rateIntraoperative
Intraoperative mean arterial pressureIntraoperative

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