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Clinical Observation of Bupivacaine Liposome for Lower Extremity Nerve Block

NCT07366905 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Patients Eligible for Elective Lower Extremity Femoral Nerve Surgery
  • Knee Arthroscopic Surgery

Interventions

DRUG

Liposomal bupivacaine, 266mg

Liposomal bupivacaine administered for ultrasound-guided femoral nerve block at varying concentrations using a modified up-and-down sequential dose-finding design.

Sponsors & Collaborators

  • The Second Affiliated Hospital of Hainan Medical University

    collaborator OTHER

  • Hainan Medical College

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-03-31
Completion
2026-04-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07366905 on ClinicalTrials.gov