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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01568476
Enrollment
88
Registered
2012-04-02
Start date
2011-07-31
Completion date
2013-06-30
Last updated
2017-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Analgesia, Regional Anesthesia, Sciatic Nerve Block

Keywords

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

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.

Interventions

PROCEDUREDistal

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

PROCEDUREInterneural

Sciatic nerve blockade at the site of bifurcation

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Block onset Timeevery 5 minutes up to 45 minutes of the block or until surgery startsWe 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.

Secondary

MeasureTime frameDescription
Nerve diameter prior to and following injectionstarting at block administration till 5 minutes after complete injection
Block procedure timestarting 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)
Extent of longitudinal local anesthetic solution spreadstarting at block administration till 5 minutes after complete injection
Incidence of block-related complicationsimmediately , at 24 hours and Post operative day 7Incidence 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
Postoperative painstarting at patient's arrival at post-anesthetic care unit till 120 minutesPostoperative 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.
Block success ratestarting after complete injection up to 45 minutes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026