Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

Not Applicable

Completed

• Conditions: Sciatic Nerve Blockade for Foot/Ankle Surgery
• Interventions: Procedure: Circumferential spread of local anesthetic; Procedure: Non-circumferential spread of local anesthetic

• Registration Number: NCT00802581
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Study Start: 2009-05
• Status Verified: 2010-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-12-08
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. English-speaking
2. ASA physical status I-III
3. 18-85 years of age, inclusive
4. 50-110 kg, inclusive
5. 150 cm of height or grater
6. Scheduled for elective foot or ankle surgery

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Exclusion Criteria

1. Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
2. Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
3. Pregnancy
4. Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
5. History of alcohol or drug dependency/abuse
6. History of long term opioid intake
7. History of significant psychiatric conditions that may affect patient assessment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Circumferential spread of local anesthetic	Ensuring circumferential spread of local anesthetic around the sciatic nerve.
2	Non-circumferential spread of local anesthetic	Single shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread.

Primary Outcome Measures

Name	Time	Method
Onset time of sciatic nerve blockade.	Every 5 minutes for 30 minutes after anesthetic injection

Secondary Outcome Measures

Name	Time	Method
Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort	24 hours

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada