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

NCT ID: NCT01568476

Last Updated: 2017-12-05

Basic Information

• 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

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.

Conditions

Post Operative Analgesia; Regional Anesthesia; Sciatic Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

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

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

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anahi Perlas, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

11-0059-A

Identifier Type: -

Identifier Source: org_study_id