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

NCT ID: NCT01643616

Last Updated: 2013-11-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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

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Other Surgical Procedures

Keywords

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Sciatic Nerve Ultrasound Anesthesia, Regional Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group US

Ultrasound guided block :

20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

Prilocaine 1%

Intervention Type DRUG

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

Ropivacaine 0.75%

Intervention Type DRUG

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

Prilocaine 1%

Intervention Type DRUG

10ml Prilocaine 1% for saphenous nerve block

ultrasound guidance

Intervention Type DEVICE

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

group NS

Nerve stimulation technique:

20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

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

Prilocaine 1%

Intervention Type DRUG

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

Ropivacaine 0.75%

Intervention Type DRUG

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

Prilocaine 1%

Intervention Type DRUG

10ml Prilocaine 1% for saphenous nerve block

nerve stimulation technique

Intervention Type DEVICE

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.

Interventions

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midazolam

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

Intervention Type DRUG

Prilocaine 1%

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

Intervention Type DRUG

Ropivacaine 0.75%

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

Intervention Type DRUG

Prilocaine 1%

10ml Prilocaine 1% for saphenous nerve block

Intervention Type DRUG

ultrasound guidance

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Dormicum Xylonest Naropin Xylonest

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helios Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr.med.Ronald Seidel

Dr.med.Ronald Seidel

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald Seidel, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Georg Rehmert, Dr. med.

Role: STUDY_DIRECTOR

Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

Other Identifiers

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HV 2010 003

Identifier Type: -

Identifier Source: org_study_id