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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01568476
Other study ID # 11-0059-A
Secondary ID
Status Completed
Phase N/A
First received March 6, 2012
Last updated December 1, 2017
Start date July 2011
Est. completion date June 2013

Study information

Verified date December 2017
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Procedure:
Distal
Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
Interneural
Sciatic nerve blockade at the site of bifurcation

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Extent of longitudinal local anesthetic solution spread starting at block administration till 5 minutes after complete injection
Secondary Nerve diameter prior to and following injection starting at block administration till 5 minutes after complete injection
Secondary Block procedure time starting at block administration till complete injection(up to 10 minutes)
Secondary Number of skin punctures required. starting at first attempt of block administration till complete injection(up to 10 minutes)
Secondary Block success rate starting after complete injection up to 45 minutes
Secondary Incidence of block-related complications Incidence of block-related complications (vascular puncture, hematoma formation, intravascular injection and post-operative neurologic deficit) will be documented, but due to the very low incidence in all block-related complications, this study is not powered to show a difference in safety immediately , at 24 hours and Post operative day 7
Secondary Postoperative pain Postoperative pain: Postoperative pain using a verbal rating score (0-10, where 0= no pain, 10=excruciating pain) at 0, 30, 60, 90 and 120 min upon admission to post-anesthetic care unit. starting at patient's arrival at post-anesthetic care unit till 120 minutes
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