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.
Conditions
Interventions
Trade Name: xylocaine (lidocaine)
Product Name: xylocaine
Pharmaceutical Form: Injection
INN or Proposed INN: xylocaine
Other descriptive name: LIDOCAINE HYDROCHLORIDE 1%
Concentration unit: % percen
Sponsors
AZ Groeninge
Eligibility
Sex/Gender
All
Inclusion criteria
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: Exclusion criteria are: age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. Our hypothesis is that the longitudinal supra-inguinal approach results in a more consistent block of the three target nerves (FN, ON, LFCN) and will have superior block characteristics. The spread of the MRI local anesthetic solution will be compared between the two techniques. The spread of injectate will be described according to the different anatomical compartments (cranial, caudal, lateral, medial spread). The involvement of the FN, ON, and LFCN will be evaluated by an independent radiologist unaware of study allocation.;Secondary Objective: Sensory block will be evaluated as described before and after the block performance by an independent examinator unaware of study allocation. The areas of sensory block will be marked on the patient and transferred to paper. A digital photograph will then be taken. This image will be analyzed using Image J software to calculate the area of anaesthesia. Post intervention strength tests. ;Primary end point(s): 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. Our hypothesis is that the longitudinal supra-inguinal approach results in a more proximal spread ijn comparison with the classical approach. ;Timepoint(s) of evaluation of this end point: Study will be performed in October 2016. Clinical data will be gathered at that point and will be analysed the weeks following the clinical days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Motor and sensory block will be measured in the FN, ON and LFCN. Our hypothesis is that the longitudinal supra-inguinal approach results in a more consistent block of the three target nerves (FN, ON, LFCN) and will have superior block characteristics. ;Timepoint(s) of evaluation of this end point: Study will be performed in October 2016. Clinical data will be gathered at that point and will be analysed the weeks following the clinical days. | — |
Countries
Belgium
Contacts
Public ContactMatthias Desmet
AZ Groeninge
Outcome results
None listed