comparison of the spread of a local anesthetic product if we inject it using two different approaches in the inguinal region using magnetic resonance imaging.

Phase 1

• Conditions: The aim of the study is to compare the spread of local anaesthetics between the classical FICB (cFICB) and the supra-inguinal FICB (sFICB). The spread of local anesthetic in the fascia iliaca compartment will be evaluated with MRI. Motor and sensory block will be measured in the FN, ON and LFCN. spread of local anesthetics will be measured.; Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]

• Registration Number: EUCTR2015-004607-24-BE
• Lead Sponsor: AZ Groeninge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-18
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

After approval of the ethics committee and written informed consent ten healthy volunteers will be randomly recruited among residents, trainees and medical students.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are: age <18 years, BMI >35, bodyweight<70kg, intolerance to local anesthetics used in the study, a history of hepatic or renal insufficiency, coagulopathy, clinical evidence of peripheral neuropathies, cardiac or pulmonary disease, abnormalities of sensory or motor function of the FN, ON or LFCN.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified