NCT01568476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1.9 years

First QC Date

March 6, 2012

Last Update Submit

December 1, 2017

Conditions

Post Operative AnalgesiaRegional AnesthesiaSciatic Nerve Block

Keywords

Regional anesthesiaSciatic nerve blockfoot surgeryankle surgeryInterneural local anesthetic

Outcome Measures

Primary Outcomes (1)

  • Block onset Time

    We aim to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation resulting in interneural spread of local anesthetic with that of blockade of each terminal nerve separately (TN and CPN), distal to sciatic nerve bifurcation. We hypothesize that sciatic nerve blockade at the site of bifurcation with interneural local anesthetic spread within a common epineural sheath results in shorter onset time compared to blockade of each terminal nerve distal to sciatic nerve bifurcation.

    every 5 minutes up to 45 minutes of the block or until surgery starts

Secondary Outcomes (7)

  • Extent of longitudinal local anesthetic solution spread

    starting at block administration till 5 minutes after complete injection

  • Nerve diameter prior to and following injection

    starting at block administration till 5 minutes after complete injection

  • Block procedure time

    starting at block administration till complete injection(up to 10 minutes)

  • Number of skin punctures required.

    starting at first attempt of block administration till complete injection(up to 10 minutes)

  • Block success rate

    starting after complete injection up to 45 minutes

  • +2 more secondary outcomes

Study Arms (2)

Distal

ACTIVE COMPARATOR

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

Procedure: Distal

Interneural

ACTIVE COMPARATOR

sciatic nerve blockade at the site of bifurcation

Procedure: Interneural

Interventions

DistalPROCEDURE

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

Distal
InterneuralPROCEDURE

Sciatic nerve blockade at the site of bifurcation

Interneural

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-III
  • years of age, inclusive
  • kg, inclusive
  • cm of height or greater

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

  • Anahi Perlas, MD, FRCPC

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

April 2, 2012

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations

CA(1)