Peripheral Nerve BlockNCT05190302
Determination of the Sensitivity, Specificity & Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During US Guided PNB
An observational study of Peripheral Nerve Block, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Block
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jan 2022to 6 Jan 2023
- Phase
- Observational
- 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
Study population: Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
Who may be able to join
- Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
Who cannot join
- Contraindications to a peripheral nerve block
- Risk of severe intoxication to local anesthesia
- Peripheral nerve block in an area not allowing neurostimulation due to absence of motor fibers (for example, adductor canal block)
- Patient refusal
- Patient unable to communicate with the health or research team
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H1L 6A1
About this study
Official title: Determination of the Sensitivity, Specificity and Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During Ultrasound Guided Peripheral Nerve Block - a Feasibility Study (StimUtile - Phase I)
Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). In addition, its use has failed to consistently prevent intra-neural injection.
The question of the usefulness of NS in addition to ultrasound is therefore still relevant. A great geographical disparity exists in the habits of nerve localization. The reluctance to use NS stems mainly from doubts about its effectiveness. The threshold used to consider that the needle is sufficiently close to the nerve and the one used to exclude an intraneural injection have been disputed in several studies. Another weakness of studies concerning NS since the advent of ultrasound guidance is the impossibility of generalizing the results. All clinical studies were performed in an academic setting, and a large majority of them specify that the blocks were performed by - or supervised by - regional anesthesia experts.
Read more
The only study that attempted to determine the sensitivity of NS used ultrasound as a gold standard. The choice of the ultrasound position as the gold standard is debatable, since it is dependent of the operator. The clinical success of nerve blocks would be a better standard.
No study to date has made it possible to calculate the specificity and sensitivity of NS in addition to ultrasound guidance, and therefore, to obtain the positive and negative predictive values of the technique. Obtaining these values could allow each clinical setting or individual to determine the contribution of NS to their rate of success, as a modest increase in the success rate or a minimal decrease in the risk of neuropathy would be clinically significant.
The hypothesis is that the sensitivity and specificity of NS justifies its use in combination with ultrasound guidance in most settings, but that the gain in efficiency varies depending on the context (for example depending on the local success rate).
To determine the required sample size to test this hypothesis and plan for a definitive study on the question, the investigators need to know what is the local failure rate (incidence of studied event) and what could be the possible rate of patient enrollment.
This preliminary, feasibility study will aim to confirm that the local failure rate is compatible with the 5% rate observed in the literature.
Read the detailed description
This study is a single-blind, prospective observational study including patients 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
This study is a phase I of a three-phases program to determine the feasibility of a larger study and to refine the sample size calculation for the phase II, currently estimated at 2,140 patients. The phase II would aim to determine whether neurostimulation improves the success rate for ultrasound-guided nerve block. If the first two phases are successful, a phase III, multicentric, will be considered to determine the usefulness of neurostimulation in addition to guidance ultrasound for the prevention of nerve complications from peripheral regional anesthesia.
The primary objective of Phase I is to determine the local failure rate of ultrasound-guided nerve block techniques, in order to refine the sample size calculation.Since patients from phase I will be included in the analysis for phase II, the study protocol and collected data will be the same as for the subsequent phases.
The secondary objectives of Phase I are to:
- Determine if a recruitment rate of three patients per day is possible
- Evaluate the staff time required for each patient recruited
- Determine if the data can be obtained completely and reliably.
The blocks included in this study are:
- Brachial plexus block by interscalene approach
- Brachial plexus block by supraclavicular approach
- Brachial plexus block by infraclavicular approach
- Specific brachial branch plexus blocks in mid-humeral, elbow or proximal part of the forearm
- Femoral nerve block by inguinal approach
- Obturator nerve block
- Sciatic nerve block by infra-gluteal approach
- Sciatic nerve block by popliteal approach
The type of block will be left to the discretion of the anesthesiologist, but must imperatively be done under real-time ultrasound guidance. Co-analgesia (Acetaminophen, Celecoxib, etc.) and sedation may be administered depending on the decisions of the treating anesthesiologist. The positioning will be left to the choice of the operator.
After the desinfection of the skin, the ultrasound will be used during the block to guide and to obtain an image of the needle point near the target (root/cord/nerve)
When the anesthesiologist is satisfied of the position, the assistant will start the neurostimulation with an intensity of 1.0 mA (Pajunk MultiStim Sensor, Germany). The intensity will be decreased to determine the value where all distal muscular response disappears. This intensity will be noted. However, the anesthesiologist will not be aware of the motor response (threshold) unless the value is below 0.3 mA. In this case, the anesthesiologist will be free to decide whether the needle should be repositionned.
Should the anesthesiologist decide to reposition the needle, the neurostimulation process will be repeated.
The anesthesiologist may then inject a small volume of dextrose 5% solution with a pressure limiting device (Nerve guard, Pajunk) to confirm adequate distribution of the solution and adequate pressure.
If unsatisfied, the anesthesiologist can again reposition the needle and repeat the neurostimulation process.Injection of dextrose prior to stimulation will be noted by the investigation team because that may change the neurostimulation profile of the targeted nerve.
Prior to the final injection of the local anesthetic, a intra-neural test dose of 3 mL will be injected to try to identify an "early block" which could underline an intra-neural positionning of the needle. In absence of immediate effect, the injection can be done according to the usual approach of the treating team.
Once in the OR, the usual maneuvers will be done to determine the efficacy of the block.
The success of the block will be documented at 30 minutes after the bloc (T1), just before the beginning of the intervention (T2) as well as at the end of the anesthesia (T3).
A phone call will be done 24 hours post-op if a unique injection was given or 24 hours after the end of the perfusion, if given in continuous infusion via catheter, to collect any complications related to the peripheral block.
Data analysis
A sample size of 200 patients was determined for phase I of this study in order to meet the primary objective.
Descriptive statistics on data relating to the research process will help determine the feasibility of the study and the resources involved.
A simple incidence calculation with confidence intervals will determine the block failure rate of the peripheral ultrasound-guided nerve block.
The average recruitment rate per day will be calculated, with confidence intervals.
The staff time required for each patient with confidence intervals will be calculated.
The clinical data will be analyzed in an exploratory manner. The data will be analyzed according to the effectiveness of the block (complete / incomplete) in relation to the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
A preliminary ROC curve will be determined by modifying the minimum threshold value and noting the effect on the neurostimulation sensitivity and specificity.
- Conditions
- Peripheral Nerve Block
- Keywords
- Neurostimulation, Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Patients undergoing regional anesthesia with a block allowing a neurostimulation. | The investigators propose to conduct a single-blind, prospective observational study on all eligible patients undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound-guided peripheral nerve block failure rate
A block will be considered a success if the patient has complete motor and sensory block, no pain or discomfort in the target area requiring the addition of any analgesic agent during surgery. A conversion to unplanned general anesthesia would constitute a failure of the block.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Secondary outcomes (6)
Recruitment rate
The number of patients recruited each day.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Recruitment time
Time required to recruit each patient.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Completeness of the data collected
Percentage of patients with complete case reports forms.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Reliability of the data collected
Average percentage of data collected/patient.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Incidence of breach in protocol
The rate of protocol deviations occurring in the study population over the time of the study.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Losses to follow-up
Number of patients who are not contacted or who withdraw from the study before the 24h follow-up.
Measured: At the end of the Phase I study, with an estimated duration of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start27 Jan 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Why it stopped: During the course of the year, we were able to answer our faisability question.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve BlockStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Garneau, MD, FRCPC, Principal investigator, Centre Hospitalier de l'Université de Montreal - CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190302
- Sponsor's protocol ID
- 21.294
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Sensitivity, Specificity and Receiver Operating Characteristic of Nerve Stimulation Receptor as a Decision-making Tool During Ultrasound Guided Peripheral Nerve Block - a Feasibility Study (StimUtile - Phase I)
- ClinicalTrials.gov ID
- NCT05190302
- Acronym / sponsor ID
- 21.294
- Conditions
- Peripheral Nerve Block
- Keywords
- Neurostimulation, Neuropathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: During the course of the year, we were able to answer our faisability question.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 13 Jan 2022 (actual)
- 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.
Although the superiority of ultrasound guidance over neurostimulation (NS) has been demonstrated, it has its limits, namely when used for a deeper block (device limits) or if used by a less experienced operator (ability to recognize structures, to correctly position the needle). In addition, its use has failed to consistently prevent intra-neural injection.
The question of the usefulness of NS in addition to ultrasound is therefore still relevant. A great geographical disparity exists in the habits of nerve localization. The reluctance to use NS stems mainly from doubts about its effectiveness. The threshold used to consider that the needle is sufficiently close to the nerve and the one used to exclude an intraneural injection have been disputed in several studies. Another weakness of studies concerning NS since the advent of ultrasound guidance is the impossibility of generalizing the results. All clinical studies were performed in an academic setting, and a large majority of them specify that the blocks were performed by - or supervised by - regional anesthesia experts.
The only study that attempted to determine the sensitivity of NS used ultrasound as a gold standard. The choice of the ultrasound position as the gold standard is debatable, since it is dependent of the operator. The clinical success of nerve blocks would be a better standard.
No study to date has made it possible to calculate the specificity and sensitivity of NS in addition to ultrasound guidance, and therefore, to obtain the positive and negative predictive values of the technique. Obtaining these values could allow each clinical setting or individual to determine the contribution of NS to their rate of success, as a modest increase in the success rate or a minimal decrease in the risk of neuropathy would be clinically significant.
The hypothesis is that the sensitivity and specificity of NS justifies its use in combination with ultrasound guidance in most settings, but that the gain in efficiency varies depending on the context (for example depending on the local success rate).
To determine the required sample size to test this hypothesis and plan for a definitive study on the question, the investigators need to know what is the local failure rate (incidence of studied event) and what could be the possible rate of patient enrollment.
This preliminary, feasibility study will aim to confirm that the local failure rate is compatible with the 5% rate observed in the literature.
Detailed description
This study is a single-blind, prospective observational study including patients 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
This study is a phase I of a three-phases program to determine the feasibility of a larger study and to refine the sample size calculation for the phase II, currently estimated at 2,140 patients. The phase II would aim to determine whether neurostimulation improves the success rate for ultrasound-guided nerve block. If the first two phases are successful, a phase III, multicentric, will be considered to determine the usefulness of neurostimulation in addition to guidance ultrasound for the prevention of nerve complications from peripheral regional anesthesia.
The primary objective of Phase I is to determine the local failure rate of ultrasound-guided nerve block techniques, in order to refine the sample size calculation.Since patients from phase I will be included in the analysis for phase II, the study protocol and collected data will be the same as for the subsequent phases.
The secondary objectives of Phase I are to:
- Determine if a recruitment rate of three patients per day is possible
- Evaluate the staff time required for each patient recruited
- Determine if the data can be obtained completely and reliably.
The blocks included in this study are:
- Brachial plexus block by interscalene approach
- Brachial plexus block by supraclavicular approach
- Brachial plexus block by infraclavicular approach
- Specific brachial branch plexus blocks in mid-humeral, elbow or proximal part of the forearm
- Femoral nerve block by inguinal approach
- Obturator nerve block
- Sciatic nerve block by infra-gluteal approach
- Sciatic nerve block by popliteal approach
The type of block will be left to the discretion of the anesthesiologist, but must imperatively be done under real-time ultrasound guidance. Co-analgesia (Acetaminophen, Celecoxib, etc.) and sedation may be administered depending on the decisions of the treating anesthesiologist. The positioning will be left to the choice of the operator.
After the desinfection of the skin, the ultrasound will be used during the block to guide and to obtain an image of the needle point near the target (root/cord/nerve)
When the anesthesiologist is satisfied of the position, the assistant will start the neurostimulation with an intensity of 1.0 mA (Pajunk MultiStim Sensor, Germany). The intensity will be decreased to determine the value where all distal muscular response disappears. This intensity will be noted. However, the anesthesiologist will not be aware of the motor response (threshold) unless the value is below 0.3 mA. In this case, the anesthesiologist will be free to decide whether the needle should be repositionned.
Should the anesthesiologist decide to reposition the needle, the neurostimulation process will be repeated.
The anesthesiologist may then inject a small volume of dextrose 5% solution with a pressure limiting device (Nerve guard, Pajunk) to confirm adequate distribution of the solution and adequate pressure.
If unsatisfied, the anesthesiologist can again reposition the needle and repeat the neurostimulation process.Injection of dextrose prior to stimulation will be noted by the investigation team because that may change the neurostimulation profile of the targeted nerve.
Prior to the final injection of the local anesthetic, a intra-neural test dose of 3 mL will be injected to try to identify an "early block" which could underline an intra-neural positionning of the needle. In absence of immediate effect, the injection can be done according to the usual approach of the treating team.
Once in the OR, the usual maneuvers will be done to determine the efficacy of the block.
The success of the block will be documented at 30 minutes after the bloc (T1), just before the beginning of the intervention (T2) as well as at the end of the anesthesia (T3).
A phone call will be done 24 hours post-op if a unique injection was given or 24 hours after the end of the perfusion, if given in continuous infusion via catheter, to collect any complications related to the peripheral block.
Data analysis
A sample size of 200 patients was determined for phase I of this study in order to meet the primary objective.
Descriptive statistics on data relating to the research process will help determine the feasibility of the study and the resources involved.
A simple incidence calculation with confidence intervals will determine the block failure rate of the peripheral ultrasound-guided nerve block.
The average recruitment rate per day will be calculated, with confidence intervals.
The staff time required for each patient with confidence intervals will be calculated.
The clinical data will be analyzed in an exploratory manner. The data will be analyzed according to the effectiveness of the block (complete / incomplete) in relation to the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
A preliminary ROC curve will be determined by modifying the minimum threshold value and noting the effect on the neurostimulation sensitivity and specificity.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I - Patients undergoing regional anesthesia with a block allowing a neurostimulation. | – | –The investigators propose to conduct a single-blind, prospective observational study on all eligible patients undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
Key inclusion criteria (1 listed)
- Patients, 18 years and older, undergoing regional anesthesia with a peripheral nerve block allowing a neurostimulation.
Key exclusion criteria (5 listed)
- Contraindications to a peripheral nerve block
- Risk of severe intoxication to local anesthesia
- Peripheral nerve block in an area not allowing neurostimulation due to absence of motor fibers (for example, adductor canal block)
- Patient refusal
- Patient unable to communicate with the health or research team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasound-guided peripheral nerve block failure rate
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
A block will be considered a success if the patient has complete motor and sensory block, no pain or discomfort in the target area requiring the addition of any analgesic agent during surgery. A conversion to unplanned general anesthesia would constitute a failure of the block.
6 secondary outcomes
Recruitment rate
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Recruitment time
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Completeness of the data collected
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Reliability of the data collected
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Incidence of breach in protocol
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Losses to follow-up
Time frame: At the end of the Phase I study, with an estimated duration of 4 months
Results and safety
The study was stopped early (reason given: During the course of the year, we were able to answer our faisability question.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Sébastien Garneau, MD, FRCPC principal investigator
Centre Hospitalier de l'Université de Montreal - CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Block, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 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: stopped early, as of the sponsor's last update on 11 Jan 2023. 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 was stopped early (reason given: During the course of the year, we were able to answer our faisability question.). Results are not available in the source record.
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?
Ultrasound-guided peripheral nerve block failure rate (time frame: At the end of the Phase I study, with an estimated duration of 4 months). 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 11 Jan 2023.