E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
In volunteers different approaches of a loco-regional anesthesia techniques will be compared by means of spread of this local anesthetic on MRI and by means of differences in muscular function tests. |
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E.1.1.2 | Therapeutic area | Health Care [N] - Health Care Quality, Access, and Evaluation [N05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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. |
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E.5.2 | 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. |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
comparison of two different approaches of a same regional anesthesia technique |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 2 |