An ultrasound guided regional anaesthesia technique study in children between 30 and 50kg: a study to prove if this technique is possible

Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
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.

Registration Number: EUCTR2013-002359-14-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intesnivmedizin und Schmerztherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Caudal block is possible for children between 30 and 50kg body weight;Secondary Objective: Secondary objectives is the theory that the spread of sensory block is higher than the anatomical spread of the local anaesthetic. <br>Another secondary objective is the hypothesis that ropivacaine plasma levels does not reach toxic levels. ;Primary end point(s): Caudal block for children with a body weight between 30 and 50kg is possible for lower body surgery;Timepoint(s) of evaluation of this end point: 15minutes after performing the caudal block surgery starts. <br>

Secondary Outcome Measures

Name	Time	Method
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;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. <br>Blood samples are taken at follwoing time points: 0, 15, 30, 45, 60, and 240 minutes after administration of ropivacaine