Sciatic Nerve Blockade for Foot/Ankle SurgeryNCT00802581
Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade
A study testing Circumferential spread of local anesthetic and Non-circumferential spread of local anesthetic in people with Sciatic Nerve Blockade for Foot/Ankle Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sciatic Nerve Blockade for Foot/Ankle Surgery
- What is being tested?
- Circumferential spread of local anesthetic and Non-circumferential spread of local anesthetic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Dec 2010
- 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
- English-speaking
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-110 kg, inclusive
- 150 cm of height or grater
- Scheduled for elective foot or ankle surgery
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 neurologic disorder affecting the lower extremity
- Pregnancy
- Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
- History of alcohol or drug dependency/abuse
- History of long term opioid intake
- History of significant psychiatric conditions that may affect patient assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Ensuring Circumferential Local Anesthetic Spread Improve the Success of Ultrasound Guided Sciatic Nerve Block at the Popliteal Fossa?
Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.
- Being tested
- Circumferential spread of local anesthetic, Non-circumferential spread of local anesthetic
- Keywords
- sciatic nerve block, local anesthetic, lidocaine, ankle surgery, foot surgery, ultrasound-guided regional anesthesia, circumferential spread, anesthetic infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circumferential spread of local anestheticProcedure or surgery
The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.
Non-circumferential spread of local anestheticProcedure or surgery
The anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ensuring circumferential spread of local anesthetic around the sciatic nerve. Receives: Procedure: Circumferential spread of local anesthetic |
| 2 | Active comparator | Single shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread. Receives: Procedure: Non-circumferential spread of local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of sciatic nerve blockade.
Measured: Every 5 minutes for 30 minutes after anesthetic injection
Secondary outcomes (1)
Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic Nerve Blockade for Foot/Ankle SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802581
- Sponsor's protocol ID
- 08-0728-B
- Status last verified
- May 2010
- First submitted
- 4 Dec 2008
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ensuring Circumferential Local Anesthetic Spread Improve the Success of Ultrasound Guided Sciatic Nerve Block at the Popliteal Fossa?
- ClinicalTrials.gov ID
- NCT00802581
- Acronym / sponsor ID
- 08-0728-B
- Keywords
- sciatic nerve block, local anesthetic, lidocaine, ankle surgery, foot surgery, ultrasound-guided regional anesthesia, circumferential spread, anesthetic infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Dec 2008 (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.
Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Circumferential spread of local anestheticEnsuring circumferential spread of local anesthetic around the sciatic nerve. |
| 2 | Active comparator | Procedure: Non-circumferential spread of local anestheticSingle shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- ASA physical status I-III
- 18-85 years of age, inclusive
- 50-110 kg, inclusive
- 150 cm of height or grater
Key exclusion criteria (7 listed)
- Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
- Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
- Pregnancy
- Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
- History of alcohol or drug dependency/abuse
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 |
|---|---|---|
| Circumferential spread of local anestheticThe anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve. | Procedure or surgery | 1 |
| Non-circumferential spread of local anestheticThe anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve. | Procedure or surgery | 2 |
Primary outcome
Onset time of sciatic nerve blockade.
Time frame: Every 5 minutes for 30 minutes after anesthetic injection
1 secondary outcome
Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort
Time frame: 24 hours
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 9 Dec 2011.
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.
Richard Brull, MD principal investigator
University Health Network, 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 Circumferential spread of local anesthetic and Non-circumferential spread of local anesthetic in people with Sciatic Nerve Blockade for Foot/Ankle Surgery, 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 6 inclusion and 7 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 9 Dec 2011. 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?
Onset time of sciatic nerve blockade. (time frame: Every 5 minutes for 30 minutes after anesthetic injection). 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 9 Dec 2011.