Minimal local anaesthetic volumes for sciatic nerve blockade: A clinical evaluation of an a volume which was used in a further volunteers study

Conditions: Patients scheduled for forefoot surgery are performed an ultrasound guided block. We will evaluate the clinical application of previously evaluated experimental data regarding volume reduction of LA´s for peripheral nerve blockade. Aim is to prove if the little amount of volume which was tested in a volunteers´study effects sufficient conditions for surgical anaesthesia and analgesia.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-005075-14-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patients undergoing plastic-reconstructive surgery in the supply area of the sciatic nerve
•Age between 18 and 90 years.
•BMI <35 kg.m-2
•Written informed consent given by patients after being provided with detailed information about name, risks and scope of the clinical study as well as the expected desirable and adverse effects of the study drug
•No legal incapacity and/or the other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Known allergy or hypersensitivity against study drug or drug class
•Participation in another clinical study
•Abnormalities in ECG that are considered clinically relevant such AV-block or bradycardia
•Unreliability or lack of cooperation
•Other objections to participate in the study in the opinion of the investigator

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the study is to investigate if the previously evaluated ED99 for ultrasound guided peripheral nerve blockade is transferable for surgical anaesthesia and analgesia.;Secondary Objective: not applicable;Primary end point(s): Achievement of anaesthesia and analgesia for surgical conditions;Timepoint(s) of evaluation of this end point: - Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minutes after the block<br>- 30minutes postoperative until full recovery<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Onset of sensory and motor blockade, duration of sensory and motor blockade;Timepoint(s) of evaluation of this end point: - Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30 and 60 minutes after the block<br>- 30minutes postoperative until full recovery<br>