ltrasound guided Caudal Blockade in children between 30 and 50kg: A Feasibility Study

Not Applicable

• Conditions: Subumbilical Surgery; K40.0; Bilateral inguinal hernia, with obstruction, without gangrene

• Registration Number: DRKS00005021
• Lead Sponsor: Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-23
• Study Completion: 2015-09-28
• Results First Posted: 2016-07-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Children with a bodyweight between 30 and 50kg undergoing subumbillical operations

Exclusion Criteria

Coagulopathy or anticoagulation therapy,
suspicion of increased intracranial pressure,
known allergy or hypersensitivity against ropivacaine or amino-amide local
anaesthetics,
signs of infection in the sacral area

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of caudal blockade in sedation for children between 30 and 50kg bodyweight.<br>Definition of successful block:<br>+ No movements of the lower extremities<br>+ No haemodynamic pain respone (heartrate increase >15% from basline)<br><br>

Secondary Outcome Measures

Name	Time	Method
+ Cranial spread of local anaesthetic within the spinal canal by real time ultrasound<br>+ Secondary spread of local anaesthetic via ultrasound <br>+ Postoperative level of the sensoric block via non-invasive and painless cold stimulation test )cool packs) every 30min until patient is discharged from the recovery room<br>+ Pharmacokinetic of ropivacaine in plasma (total concentration) is determined by gas chromatography-mass spectometry (GC-MS) at time 0, 15, 30, 45, 60 and 240 minutes after caudal blockade (ropivacain injection).<br>