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Completed

NCT Number: NCT01643616

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

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.

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Key information

Conditions

Other Surgical Procedures

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

Other names: Dormicum

prilocaine 1%

Drug

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

Other names: Xylonest

Ropivacaine 0.75%

Drug

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

Other names: Naropin

Ultrasound guidance

Device

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

nerve stimulation technique

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.

Primary outcomes

  1. Success Rate Without Supplementation

    Time frame: within 30-60 minutes after injection of the local anesthetic

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

    • success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
    • 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)
    • failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division

  2. Time Until Readiness for Surgery (Minutes)

    Time frame: within 60 minutes after injection of the local anesthetic

  3. Success Rate With Supplementation

    Time frame: later than 30-60 minutes after injection of the local anesthetic

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

    • success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)
    • 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)
    • failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation

Sponsors and collaborators

Lead sponsor

Helios Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2012
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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