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

NCT ID: NCT01568476

Last Updated: 2017-12-05

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

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Analgesia Regional Anesthesia Sciatic Nerve Block

Keywords

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Regional anesthesia Sciatic nerve block foot surgery ankle surgery Interneural local anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Distal

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

Group Type ACTIVE_COMPARATOR

Distal

Intervention Type PROCEDURE

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

Interneural

sciatic nerve blockade at the site of bifurcation

Group Type ACTIVE_COMPARATOR

Interneural

Intervention Type PROCEDURE

Sciatic nerve blockade at the site of bifurcation

Interventions

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Distal

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

Intervention Type PROCEDURE

Interneural

Sciatic nerve blockade at the site of bifurcation

Intervention Type PROCEDURE

Eligibility Criteria

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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
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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Anahi Perlas, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of 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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11-0059-A

Identifier Type: -

Identifier Source: org_study_id