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Completed

NCT Number: NCT01568476

Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?

Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa, the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN). Studies have shown that when both branches are blocked separately distal to the bifurcation site, block onset time is reduced by 30%. Through clinical observation, the investigators found that onset time is further shortened when ultrasound-guided SNB is performed at the site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and CPN) distal to sciatic nerve bifurcation.

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Key information

Conditions

Post Operative Analgesia Regional Anesthesia Sciatic Nerve Block

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I-III
  • 18-85 years of age, inclusive
  • 50-120 kg, inclusive
  • 150 cm of height or greater

Exclusion criteria

  • Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
  • Significant peripheral neuropathy or neurological disorder affecting the lower extremity
  • Pregnancy
  • History of alcohol or drug dependency/abuse
  • History of significant psychiatric conditions that may affect patient assessment

Treatment and study plan

Distal

Procedure

Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation

Interneural

Procedure

Sciatic nerve blockade at the site of bifurcation

Primary outcomes

  1. Block onset Time

    Time frame: every 5 minutes up to 45 minutes of the block or until surgery starts

    We aim to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation resulting in interneural spread of local anesthetic with that of blockade of each terminal nerve separately (TN and CPN), distal to sciatic nerve bifurcation. We hypothesize that sciatic nerve blockade at the site of bifurcation with interneural local anesthetic spread within a common epineural sheath results in shorter onset time compared to blockade of each terminal nerve distal to sciatic nerve bifurcation.

Secondary outcomes

  1. Extent of longitudinal local anesthetic solution spread

    Time frame: starting at block administration till 5 minutes after complete injection

  2. Nerve diameter prior to and following injection

    Time frame: starting at block administration till 5 minutes after complete injection

  3. Block procedure time

    Time frame: starting at block administration till complete injection(up to 10 minutes)

  4. Number of skin punctures required.

    Time frame: starting at first attempt of block administration till complete injection(up to 10 minutes)

  5. Block success rate

    Time frame: starting after complete injection up to 45 minutes

  6. Incidence of block-related complications

    Time frame: immediately , at 24 hours and Post operative day 7

    Incidence of block-related complications (vascular puncture, hematoma formation, intravascular injection and post-operative neurologic deficit) will be documented, but due to the very low incidence in all block-related complications, this study is not powered to show a difference in safety

  7. Postoperative pain

    Time frame: starting at patient's arrival at post-anesthetic care unit till 120 minutes

    Postoperative pain: Postoperative pain using a verbal rating score (0-10, where 0= no pain, 10=excruciating pain) at 0, 30, 60, 90 and 120 min upon admission to post-anesthetic care unit.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 2, 2012
Registry last updated
Dec 5, 2017

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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