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.
Conditions
Interventions
Trade Name: Naropin 3.8mg/ml
Product Name: Ropivacain
Product Code: 1–21500
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ropivacaine
CAS Number: 132112-35-7
Current Sponsor code: 1
Sponsors
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intesnivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Blood samples are taken at follwoing time points: 0, 15, 30, 45, 60, and 240 minutes after administration of ropivacaine | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intesnivmedizin und Schmerztherapie
Outcome results
None listed