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

Helios Research Center

Status: Completed

Conditions: Other Surgical Procedures

Treatments: Device: nerve stimulation technique; Device: ultrasound guidance; Drug: Ropivacaine 0.75%; Drug: midazolam; Drug: Prilocaine 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT01643616

HV 2010 003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective surgery on the foot or ankle
• tourniquet distal of the knee
• adult patients, 18-75 years old
• ASA-risk-groups I-III (American Society of Anesthesiologists)
• informed consent

Exclusion criteria

• severe coagulopathy
• systemic inflammatory response
• ASA-risk-groups > III (American Society of Anesthesiologists)
• drug allergy: local anesthetics
• pregnancy, lactation period
• participation in other studies
• addiction to drugs or alcohol
• non-cooperative patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

group US

Active Comparator group

Description:

Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Treatment:

Drug: Prilocaine 1%

Drug: midazolam

Drug: Ropivacaine 0.75%

Device: ultrasound guidance

Drug: Prilocaine 1%

group NS

Active Comparator group

Description:

Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Treatment:

Drug: Prilocaine 1%

Drug: midazolam

Drug: Ropivacaine 0.75%

Device: nerve stimulation technique

Drug: Prilocaine 1%