NCT01643616

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Helios Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve stimulation technique)assumed that the target is a close approximation to the nerve, without epineural perforation. Intraneural injections were considered as evitable, with high risk for nerve damages. Ultrasound guidance provided for the first time a real-time visualization of the spread of local anesthetic. Some recent studies proved, that an intraneural injection using nerve stimulator technique is common and not necessarily accompanied with nerve damages. In the ultrasound group (group US) the investigators tested the hypothesis, that an intraneural injection of local anesthetic generate a high success rate and a short onset time without clinical apparent nerve damages. In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an intraneural injection of local anesthetic is common, and in case of intraneural injection accompanied likewise with high success rate and shorter onset time. For the sciatic division the investigators tested the hypothesis, that classical methods of nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid epineural perforation.

Conditions

• Other Surgical Procedures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2012-09-01
• First posted: 2012-07-18
• Last updated: 2013-11-01
• Results posted: 2013-11-01