Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr.med.Ronald Seidel, Helios Research Center
ClinicalTrials.gov Identifier:
NCT01643616
First received: July 16, 2012
Last updated: July 22, 2012
Last verified: July 2012
History of Changes
  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%

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:

U.S. FDA Resources

Further study details as provided by Helios Research Center:

Primary Outcome Measures:
  • success rate [ 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
    2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required
    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 ]

Estimated Enrollment: 250
Study Start Date: November 2010
Estimated Study Completion Date: August 2012
Primary Completion Date: December 2011 (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
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

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
  • drug allergy: local anesthetics
  • pregnancy, lactation period
  • participation in other studies
  • addiction to drugs or alcohol
  • non-cooperative patients
  Contacts and Locations
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
Last Updated: July 22, 2012
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
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013