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Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

NCT ID: NCT00802581

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Sciatic Nerve Blockade for Foot/Ankle Surgery

Keywords

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sciatic nerve block local anesthetic lidocaine ankle surgery foot surgery ultrasound-guided regional anesthesia circumferential spread anesthetic infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Ensuring circumferential spread of local anesthetic around the sciatic nerve.

Group Type EXPERIMENTAL

Circumferential spread of local anesthetic

Intervention Type PROCEDURE

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

2

Single shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread.

Group Type ACTIVE_COMPARATOR

Non-circumferential spread of local anesthetic

Intervention Type 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.

Interventions

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Circumferential spread of local anesthetic

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

Intervention Type PROCEDURE

Non-circumferential spread of local anesthetic

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Brull, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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08-0728-B

Identifier Type: -

Identifier Source: org_study_id