Post Operative AnalgesiaNCT01568476
Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?
A study testing Distal and Interneural in people with Post Operative Analgesia and Regional Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Analgesia, Regional Anesthesia, Sciatic Nerve Block
- What is being tested?
- Distal and Interneural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-120 kg, inclusive
- 150 cm of height or greater
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Distal, Interneural
- Keywords
- Regional anesthesia, Sciatic nerve block, foot surgery, ankle surgery, Interneural local anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DistalProcedure or surgery
Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
InterneuralProcedure or surgery
Sciatic nerve blockade at the site of bifurcation
| Study group | Role | What they receive |
|---|---|---|
| Distal | Active comparator | Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation Receives: Procedure: Distal |
| Interneural | Active comparator | sciatic nerve blockade at the site of bifurcation Receives: Procedure: Interneural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 5 minutes up to 45 minutes of the block or until surgery starts
Secondary outcomes (7)
Extent of longitudinal local anesthetic solution spread
Measured: starting at block administration till 5 minutes after complete injection
Nerve diameter prior to and following injection
Measured: starting at block administration till 5 minutes after complete injection
Block procedure time
Measured: starting at block administration till complete injection(up to 10 minutes)
Number of skin punctures required.
Measured: starting at first attempt of block administration till complete injection(up to 10 minutes)
Block success rate
Measured: starting after complete injection up to 45 minutes
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
Measured: immediately , at 24 hours and Post operative day 7
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.
Measured: starting at patient's arrival at post-anesthetic care unit till 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568476
- Sponsor's protocol ID
- 11-0059-A
- Status last verified
- Dec 2017
- First submitted
- 6 Mar 2012
- Last updated
- 5 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?
- ClinicalTrials.gov ID
- NCT01568476
- Acronym / sponsor ID
- 11-0059-A
- Keywords
- Regional anesthesia, Sciatic nerve block, foot surgery, ankle surgery, Interneural local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal | Active comparator | Procedure: DistalBlockade of both terminal branches of Sciatic nerve separately, distal to bifurcation |
| Interneural | Active comparator | Procedure: Interneuralsciatic nerve blockade at the site of bifurcation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-120 kg, inclusive
- 150 cm of height or greater
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DistalBlockade of both terminal branches of Sciatic nerve separately, distal to bifurcation | Procedure or surgery | Distal |
| InterneuralSciatic nerve blockade at the site of bifurcation | Procedure or surgery | Interneural |
Primary outcome
Block onset Time
Time frame: every 5 minutes up to 45 minutes of the block or until surgery starts
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.
7 secondary outcomes
Extent of longitudinal local anesthetic solution spread
Time frame: starting at block administration till 5 minutes after complete injection
Nerve diameter prior to and following injection
Time frame: starting at block administration till 5 minutes after complete injection
Block procedure time
Time frame: starting at block administration till complete injection(up to 10 minutes)
Number of skin punctures required.
Time frame: starting at first attempt of block administration till complete injection(up to 10 minutes)
Block success rate
Time frame: starting after complete injection up to 45 minutes
Incidence of block-related complications
Time frame: immediately , at 24 hours and Post operative day 7
Postoperative pain
Time frame: starting at patient's arrival at post-anesthetic care unit till 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anahi Perlas, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal and Interneural in people with Post Operative Analgesia and Regional Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block onset Time (time frame: every 5 minutes up to 45 minutes of the block or until surgery starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.