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OpenTrials
Completed

NCT Number: NCT00802581

Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5W 2S8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English-speaking
  • ASA physical status I-III
  • 18-85 years of age, inclusive
  • 50-110 kg, inclusive
  • 150 cm of height or grater
  • Scheduled for elective foot or ankle surgery

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 neurologic disorder affecting the lower extremity
  • Pregnancy
  • Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
  • History of alcohol or drug dependency/abuse
  • History of long term opioid intake
  • History of significant psychiatric conditions that may affect patient assessment

Treatment and study plan

Circumferential spread of local anesthetic

Procedure

The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.

Non-circumferential spread of local anesthetic

Procedure

The anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve.

Primary outcomes

  1. Onset time of sciatic nerve blockade.

    Time frame: Every 5 minutes for 30 minutes after anesthetic injection

Secondary outcomes

  1. Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Does Ensuring Circumferential Local Anesthetic Spread Improve the Success of Ultrasound Guided Sciatic Nerve Block at the Popliteal Fossa?

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2008
Registry last updated
Dec 9, 2011

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.