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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, Helios Research Center
ClinicalTrials.gov Identifier:
NCT01643616
First received: July 16, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Other Surgical Procedures
Drug: midazolam
Drug: Prilocaine 1%
Drug: Ropivacaine 0.75%
Device: ultrasound guidance
Device: nerve stimulation technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique

Resource links provided by NLM:


Further study details as provided by Helios Research Center:

Primary Outcome Measures:
  • Success Rate Without Supplementation [ Time Frame: within 30-60 minutes after injection of the local anesthetic ] [ Designated as safety issue: No ]

    After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.

    1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
    2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)
    3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division

  • Time Until Readiness for Surgery (Minutes) [ Time Frame: within 60 minutes after injection of the local anesthetic ] [ Designated as safety issue: No ]
  • Success Rate With Supplementation [ Time Frame: later than 30-60 minutes after injection of the local anesthetic ] [ Designated as safety issue: No ]

    After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.

    1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
    2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)
    3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation


Enrollment: 250
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group US

Ultrasound guided block :

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

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).
Other Name: Dormicum
Drug: Prilocaine 1%
20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)
Other Name: Xylonest
Drug: Ropivacaine 0.75%
10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)
Other Name: Naropin
Drug: Prilocaine 1%
10ml Prilocaine 1% for saphenous nerve block
Other Name: Xylonest
Device: ultrasound guidance
In group US the sciatic nerve localization and needle guidance is realized using ultrasound.
Active Comparator: group NS

Nerve stimulation technique:

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

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).
Other Name: Dormicum
Drug: Prilocaine 1%
20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)
Other Name: Xylonest
Drug: Ropivacaine 0.75%
10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)
Other Name: Naropin
Drug: Prilocaine 1%
10ml Prilocaine 1% for saphenous nerve block
Other Name: Xylonest
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01643616

Sponsors and Collaborators
Helios Research Center
Investigators
Principal Investigator: Ronald Seidel, Dr. med. Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
Study Director: Georg Rehmert, Dr. med. Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
  More Information

No publications provided

Responsible Party: Dr.med.Ronald Seidel, Helios Research Center
ClinicalTrials.gov Identifier: NCT01643616     History of Changes
Other Study ID Numbers: HV 2010 003
Study First Received: July 16, 2012
Results First Received: March 21, 2013
Last Updated: August 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Helios Research Center:
Sciatic Nerve
Ultrasound
Anesthesia, Regional
Orthopedic Surgery

Additional relevant MeSH terms:
Prilocaine
Ropivacaine
Midazolam
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014