Regional AnesthesiaNCT02721290
Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using Two Femoral Block Techniques
A study testing Femoral nerve block using Ultrasound and neurostimulator, Femoral nerve block using Ultrasound and Ropivacaine 0.5% in people with Regional Anesthesia and Femoral Nerve Block, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia, Femoral Nerve Block
- What is being tested?
- Femoral nerve block using Ultrasound and neurostimulator, Femoral nerve block using Ultrasound and Ropivacaine 0.5%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.
Who cannot join
- Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
- Refusal to participate in the study
- Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Cédric Godbout-Simard, MD, 5147151723, cedric.godboutsimard@mail.mcgill.ca
About this study
Official title: Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using an Ultrasound Plus Neurostimulator Technique Versus an Approach Based on the Localization of the Femoral Artery.
In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.
- Conditions
- Regional Anesthesia, Femoral Nerve Block
- Being tested
- Femoral nerve block using Ultrasound and neurostimulator, Femoral nerve block using Ultrasound, Ropivacaine 0.5%
- Keywords
- Knee surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve block using Ultrasound and neurostimulatorProcedure or surgery
Femoral nerve block using UltrasoundProcedure or surgery
Ropivacaine 0.5%Drug
Ropivacaine 0.5% (20cc total) will be injected for the performance of the block in the two arms of the study.
| Study group | Role | What they receive |
|---|---|---|
| Femoral nerve block using Ultrasound and neurostimulator | Active comparator | Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%. Receives: Procedure: Femoral nerve block using Ultrasound and neurostimulator; Drug: Ropivacaine 0.5% |
| Femoral nerve block using femoral artery target | Experimental | Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%. Receives: Procedure: Femoral nerve block using Ultrasound; Drug: Ropivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitive cutaneous block distribution area for the two techniques
After performance of a femoral nerve block, ice will be applied on the skin to plot the anesthetized area at times 15, 30 and 45 mn. The sensation will be compared on a scale from 0 (no sensation) to 2 (no anesthesia) with the contralateral leg. An area in cm2 will be calculated for each of the patients and the two techniques will then be compared.
Measured: 45 minutes
Secondary outcomes (7)
Time of block completion
Time recorded from the end of the cutaneous local anesthetic injection to the end of the 20cc injection of the 0.5% Ropivacaine (time of block completion)
Measured: 45 minutes
Ease of ultrasound visualization of the femoral nerve
This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Measured: 45 minutes
Ease of ultrasound visualization of the femoral artery
This will be assessed by the anesthesiologist making the femoral nerve block from a scale of 1 (no visualization) to 10 (excellent visualization).
Measured: 45 minutes
Numbers of needle redirection
The number of time for each patients using either techniques that the needle will have been withdrawn.
Measured: 45 minutes
Vascular puncture
Presence or absence of blood return at anytime in the tubing while performing the block.
Measured: 45 minutes
Paresthesia
Presence or absence of the sensation of electrical shock felt by the patient in the territory of the femoral nerve at any point while performing the block
Measured: 45 minutes
Patient Satisfaction
Satisfaction expressed by the patient after the completion of the femoral nerve block using a scale from 1 to 4.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Issam TANOUBI, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721290
- Sponsor's protocol ID
- 20160112
- Status last verified
- Aug 2019
- First submitted
- 15 Mar 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using an Ultrasound Plus Neurostimulator Technique Versus an Approach Based on the Localization of the Femoral Artery.
- ClinicalTrials.gov ID
- NCT02721290
- Acronym / sponsor ID
- 20160112
- Conditions
- Regional Anesthesia, Femoral Nerve Block
- Keywords
- Knee surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Mar 2016 (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.
In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral nerve block using Ultrasound and neurostimulator | Active comparator | Procedure: Femoral nerve block using Ultrasound and neurostimulator, Drug: Ropivacaine 0.5%Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%. |
| Femoral nerve block using femoral artery target | Experimental | Procedure: Femoral nerve block using Ultrasound, Drug: Ropivacaine 0.5%Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.
Key exclusion criteria (3 listed)
- Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
- Refusal to participate in the study
- Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.
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 |
|---|---|---|
| Femoral nerve block using Ultrasound and neurostimulator | Procedure or surgery | Femoral nerve block using Ultrasound and neurostimulator |
| Femoral nerve block using Ultrasound | Procedure or surgery | Femoral nerve block using femoral artery target |
| Ropivacaine 0.5%Ropivacaine 0.5% (20cc total) will be injected for the performance of the block in the two arms of the study. | Drug | Femoral nerve block using Ultrasound and neurostimulator, Femoral nerve block using femoral artery target |
Primary outcome
Sensitive cutaneous block distribution area for the two techniques
Time frame: 45 minutes
After performance of a femoral nerve block, ice will be applied on the skin to plot the anesthetized area at times 15, 30 and 45 mn. The sensation will be compared on a scale from 0 (no sensation) to 2 (no anesthesia) with the contralateral leg. An area in cm2 will be calculated for each of the patients and the two techniques will then be compared.
7 secondary outcomes
Time of block completion
Time frame: 45 minutes
Ease of ultrasound visualization of the femoral nerve
Time frame: 45 minutes
Ease of ultrasound visualization of the femoral artery
Time frame: 45 minutes
Numbers of needle redirection
Time frame: 45 minutes
Vascular puncture
Time frame: 45 minutes
Paresthesia
Time frame: 45 minutes
Patient Satisfaction
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block using Ultrasound and neurostimulator, Femoral nerve block using Ultrasound and Ropivacaine 0.5% in people with Regional Anesthesia and Femoral Nerve Block, run by Maisonneuve-Rosemont Hospital 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Issam Tanoubi, MD (1 844 634-3400 ext. 3808, i.tanoubi@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitive cutaneous block distribution area for the two techniques (time frame: 45 minutes). 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 30 Aug 2019.