E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
combined femoral and sciatic nerve block for lower extremity orthopedic surgery |
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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 purpose of the present pilot study is to obtain a pharmacokinetic profile of ropivacaine in serum with epinephrine, and of ropivacaine in serum without epinephrine, used for high dosed combined femoral and sciatic nerve block in lower extremity orthopedic surgery. Results of this pilot study will be used in a follow-up study to determine block specific maximum doses using the determined width of Cmax found in this study. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients ≥ 18 years, ≤ 60 years - Body Weight ≥ 70 kg - ASA classification I – III - Patients undergoing combined femoral and sciatic nerve block for lower extremity orthopaedic surgery - Who will be admitted for at least 48 hours - Written informed consent
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E.4 | Principal exclusion criteria |
- Contra-indications for regional anesthesia (infection at the injection site, coagulopathy) - Known hypersensitivity to amide-type local anesthetics - Known history of peripheral neuropathy - Hepatic or renal insufficiency - Use of fluvoxamine, ciprofloxacin, ketoconazole, erythromycin, clarithromycin, itraconazole, or rifampicin because of their effect on ropivacaine clearance.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Mean unbound and bound peak plasma concentration (Cmax) of ropivacaine with and without epinephrine 2. Mean time to unbound and bound peak plasma concentration (Tmax) of ropivacaine with and without epinephrine 3. Range of duration (width) of Cmax¬ after single shot combined femoral and sciatic nerve block with and without epinephrine 4. Range of apparent half-life of ropivacaine with and without epinephrine in combined femoral and sciatic nerve block (T½). 5. Efficacy of the sensory blockade with and without epinephrine. 6. Duration of the sensory blockade with and without epinephrine.
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
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 |
randomized addition of epinephrine |
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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 | Information not present in EudraCT |
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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The trial ends when 12 evaluable patients have been included and studied. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |