E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Caudal block is a very well established method to anaesthesize children for lower body surgery until they have a body weight up to 25kg. We would like to prove that it is also possible to perform a caudal block for bigger chidlren between 30 and 50kg. Performing the block takes place by ultrasound controlling.
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E.1.1.1 | Medical condition in easily understood language |
Caudal block is a kind of regional anaeshesia for children. It will be done for children up to 25kg body weight. We want to show that caudal block is also possible for children between 30 and 50kg. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
Caudal block is possible for children between 30 and 50kg body weight |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives is the theory that the spread of sensory block is higher than the anatomical spread of the local anaesthetic. Another secondary objective is the hypothesis that ropivacaine plasma levels does not reach toxic levels. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients between 30 and 50 kg bodyweight undergoing subumbilical surgery •Written informed consent given by the parents/child after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects. •No legal incapacity and/or other circumstances rendering the parents/child unable to understand the nature, scope and possible consequences of the study
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E.4 | Principal exclusion criteria |
•Parents or Child’s refusal •Coagulopathy or anticoagulation therapy •Suspicion of increased intracranial pressure •Known allergy or hypersensitivity against Ropivacaine or amino-amide local anaesthetics •Anatomical abnormalities of the limb or lower spine region •Participation in another clinical study within the last 4 weeks prior to study •Abnormalities in ECG that are considered clinically relevant such as AV-block or bradycardia •Other objections to participate in the study in the opinion of the investigator Study Protocol / Methods
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E.5 End points |
E.5.1 | Primary end point(s) |
Caudal block for children with a body weight between 30 and 50kg is possible for lower body surgery |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
15minutes after performing the caudal block surgery starts.
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E.5.2 | Secondary end point(s) |
Secondary endpoints are the the evaluation of the cranial sensory spread of the local anaesthetic and the evaluation of the plasma levels of ropivacaine |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
To determine the dermatomal level of sensory block evaluation takes place by cold packs and touch stimulation postoperatively in postoperative care unit. Blood samples are taken at follwoing time points: 0, 15, 30, 45, 60, and 240 minutes after administration of ropivacaine |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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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After discharge of the postoperative care unit the study is finished for the subject. If there are any problems an anaeshesist concerned with the study is available 24 hours. |
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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 |