Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique

NCT01643616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-11-01

Study results available
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Summary

For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.

Conditions

  • Other Surgical Procedures

Interventions

DRUG

midazolam

Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).

DRUG

Prilocaine 1%

20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)

DRUG

Ropivacaine 0.75%

10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)

DRUG

Prilocaine 1%

10ml Prilocaine 1% for saphenous nerve block

DEVICE

ultrasound guidance

In group US the sciatic nerve localization and needle guidance is realized using ultrasound.

DEVICE

nerve stimulation technique

In the group NS sciatic nerve localization and needle guidance is realized using nerve stimulation technique. However, ultrasound is used observing (Observer) the procedure, but blinded for the physician (Anesthetist) performing the block.

Sponsors & Collaborators

  • Helios Research Center

    lead OTHER

Principal Investigators

  • Ronald Seidel, Dr. med. · Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

  • Georg Rehmert, Dr. med. · Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-06-30
Completion
2012-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643616 on ClinicalTrials.gov