Regional AnesthesiaNCT03797235
The Impact of Nerve Cross Section Area on Sensory Block Onset
A study testing Dominant Arm and Non-dominant arm in people with Regional Anesthesia, run by Jose Aguirre at 1 site in Switzerland.
Trial summary
The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Dominant Arm and Non-dominant arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Jan 2019to 21 Jun 2019
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I - II, both sexes
- ≥ 18 years old
- < 65 years old
- Written informed consent as documented by signature
Who cannot join
- Known allergy or hypersensitivity to a study drug or class of drug.
- Severe coagulopathy.
- History of alcohol abuse or the intake of psychotropic drugs.
- Pregnancy.
- Infection at the injection site or a systemic infection.
- Fever of unknown origin.
- Motor or sensory abnormalities in the arm.
- Previous enrollment into the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Nerve Cross Section Area on Sensory Block Onset. A Prospective, Monocentric Crossover Study on Volunteers
The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation.
In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.
- Conditions
- Regional Anesthesia
- Being tested
- Dominant Arm, Non-dominant arm
- Keywords
- Ultrasound-guided regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dominant ArmProcedure or surgery
The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.
Non-dominant armProcedure or surgery
The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.
| Study group | Role | What they receive |
|---|---|---|
| Dominant Arm | Experimental | Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the dominant forearm Receives: Procedure: Dominant Arm |
| Non-dominant arm | Active comparator | Two ultrasound guided nerve blocks (block of the ulnar and median nerve) on the non-dominant forearm. Receives: Procedure: Non-dominant arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between nerve cross-section and time to complete sensory block of a nerve
Correlation between the nerve cross-section in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the moment the investigator starts injecting the local anesthetic (LA) around the respective nerves to complete sensory loss in the innervation area of the blocked nerve, assessed by response to light touch, pinprick and cold sensation. This correlation will be expressed in min/ mm2.
Measured: Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes
Secondary outcomes (3)
Correlation between nerve cross-section and time to complete motor block of a nerve
The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the start of the LA injection around the nerve median and ulnar nerves to the respective onset of the motor block, assessed with a numerical scale ranging from 0 to 5 (0-no muscle contraction visible, 5-normal muscle strength, maximal force against resistance and gravity). This correlation will be expressed in min/ mm2.
Measured: Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes
Correlation between nerve cross-section and the duration of sensory nerve block
The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective sensory block in minutes, as reflected by the return of normal sensation in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2.
Measured: The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes
Correlation between the nerve cross-section and duration of motor nerve block
The correlation between the nerve cross-section area in mm2 of both nerves (median and ulnar) measured with an ultrasound system and the duration of the respective motor block in minutes, as reflected by the return of normal muscle strength in the innervation area of the respective nerve. This correlation will be expressed in min/ mm2.
Measured: The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start19 Jan 2019
- Primary completion20 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Aguirre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Aguirre, Balgrist University Hospital
- Investigators
- José Aguirre, PD Dr Med, Principal investigator, Der Balgrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797235
- Sponsor's protocol ID
- BASEC 2018-00939
- Status last verified
- May 2020
- First submitted
- 5 Jan 2019
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capdevila X, Biboulet P, Morau D, Mannion S, Choquet O. How and why to use ultrasound for regional blockade. Acta Anaesthesiol Belg. 2008;59(3):147-54.
PubMed 19051446Lewis SR, Price A, Walker KJ, McGrattan K, Smith AF. Ultrasound guidance for upper and lower limb blocks. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD006459. doi: 10.1002/14651858.CD006459.pub3.
PubMed 26361135Eichenberger U, Stockli S, Marhofer P, Huber G, Willimann P, Kettner SC, Pleiner J, Curatolo M, Kapral S. Minimal local anesthetic volume for peripheral nerve block: a new ultrasound-guided, nerve dimension-based method. Reg Anesth Pain Med. 2009 May-Jun;34(3):242-6. doi: 10.1097/AAP.0b013e31819a7225.
PubMed 19587623Keplinger M, Marhofer P, Marhofer D, Schroegendorfer K, Haslik W, Zeitlinger M, Mayer CV, Kettner SC. Effective local anaesthetic volumes for sciatic nerve blockade: a clinical evaluation of the ED99. Anaesthesia. 2015 May;70(5):585-90. doi: 10.1111/anae.13013. Epub 2015 Jan 20.
PubMed 25644578Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
PubMed 25376973Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0.
PubMed 26423050Serradell A, Herrero R, Villanueva JA, Santos JA, Moncho JM, Masdeu J. Comparison of three different volumes of mepivacaine in axillary plexus block using multiple nerve stimulation. Br J Anaesth. 2003 Oct;91(4):519-24. doi: 10.1093/bja/aeg215.
PubMed 14504153Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.
PubMed 22664978Latzke D, Marhofer P, Zeitlinger M, Machata A, Neumann F, Lackner E, Kettner SC. Minimal local anaesthetic volumes for sciatic nerve block: evaluation of ED 99 in volunteers. Br J Anaesth. 2010 Feb;104(2):239-44. doi: 10.1093/bja/aep368. Epub 2009 Dec 23.
PubMed 20034967Ecoffey C, Oger E, Marchand-Maillet F, Cimino Y, Rannou JJ, Beloeil H; SOS French Regional Anaesthesia Hotline. Complications associated with 27 031 ultrasound-guided axillary brachial plexus blocks: a web-based survey of 36 French centres. Eur J Anaesthesiol. 2014 Nov;31(11):606-10. doi: 10.1097/EJA.0000000000000063.
PubMed 24809480Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.
PubMed 21148659Hebl JR. The importance and implications of aseptic techniques during regional anesthesia. Reg Anesth Pain Med. 2006 Jul-Aug;31(4):311-23. doi: 10.1016/j.rapm.2006.04.004. No abstract available.
PubMed 16857551Rotter ML, Hirschl AM, Koller W. Effect of chlorhexidine-containing detergent, non-medicated soap or isopropanol and the influence of neutralizer on bacterial pathogenicity. J Hosp Infect. 1988 Apr;11(3):220-5. doi: 10.1016/0195-6701(88)90100-4.
PubMed 2899106Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.
PubMed 20121770
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nerve Cross Section Area on Sensory Block Onset. A Prospective, Monocentric Crossover Study on Volunteers
- ClinicalTrials.gov ID
- NCT03797235
- Acronym / sponsor ID
- BASEC 2018-00939
- Conditions
- Regional Anesthesia
- Keywords
- Ultrasound-guided regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jose AguirreUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 9 Jan 2019 (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.
The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation.
In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dominant Arm | Experimental | Procedure: Dominant ArmTwo ultrasound guided nerve blocks (block of the ulnar and median nerve) on the dominant forearm |
| Non-dominant arm | Active comparator | Procedure: Non-dominant armTwo ultrasound guided nerve blocks (block of the ulnar and median nerve) on the non-dominant forearm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I - II, both sexes
- ≥ 18 years old
- < 65 years old
- Written informed consent as documented by signature
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to a study drug or class of drug.
- Severe coagulopathy.
- History of alcohol abuse or the intake of psychotropic drugs.
- Pregnancy.
- Infection at the injection site or a systemic infection.
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 |
|---|---|---|
| Dominant ArmThe volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve. | Procedure or surgery | Dominant Arm |
| Non-dominant armThe volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve. | Procedure or surgery | Non-dominant arm |
Primary outcome
Correlation between nerve cross-section and time to complete sensory block of a nerve
Time frame: Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes
Correlation between the nerve cross-section in mm2 of both nerves (median and ulnar) measured with an ultrasound system and time in minutes from the moment the investigator starts injecting the local anesthetic (LA) around the respective nerves to complete sensory loss in the innervation area of the blocked nerve, assessed by response to light touch, pinprick and cold sensation. This correlation will be expressed in min/ mm2.
3 secondary outcomes
Correlation between nerve cross-section and time to complete motor block of a nerve
Time frame: Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes
Correlation between nerve cross-section and the duration of sensory nerve block
Time frame: The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes
Correlation between the nerve cross-section and duration of motor nerve block
Time frame: The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min
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 22 May 2020.
- Background: PubMed 19051446Capdevila X, Biboulet P, Morau D, Mannion S, Choquet O. How and why to use ultrasound for regional blockade. Acta Anaesthesiol Belg. 2008;59(3):147-54.
- Background: PubMed 26361135Lewis SR, Price A, Walker KJ, McGrattan K, Smith AF. Ultrasound guidance for upper and lower limb blocks. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD006459. doi: 10.1002/14651858.CD006459.pub3.
- Background: PubMed 19587623Eichenberger U, Stockli S, Marhofer P, Huber G, Willimann P, Kettner SC, Pleiner J, Curatolo M, Kapral S. Minimal local anesthetic volume for peripheral nerve block: a new ultrasound-guided, nerve dimension-based method. Reg Anesth Pain Med. 2009 May-Jun;34(3):242-6. doi: 10.1097/AAP.0b013e31819a7225.
- Background: PubMed 25644578Keplinger M, Marhofer P, Marhofer D, Schroegendorfer K, Haslik W, Zeitlinger M, Mayer CV, Kettner SC. Effective local anaesthetic volumes for sciatic nerve blockade: a clinical evaluation of the ED99. Anaesthesia. 2015 May;70(5):585-90. doi: 10.1111/anae.13013. Epub 2015 Jan 20.
- Background: PubMed 25376973Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
- Background: PubMed 26423050Fenten MG, Schoenmakers KP, Heesterbeek PJ, Scheffer GJ, Stienstra R. Effect of local anesthetic concentration, dose and volume on the duration of single-injection ultrasound-guided axillary brachial plexus block with mepivacaine: a randomized controlled trial. BMC Anesthesiol. 2015 Sep 30;15:130. doi: 10.1186/s12871-015-0110-0.
- Background: PubMed 14504153Serradell A, Herrero R, Villanueva JA, Santos JA, Moncho JM, Masdeu J. Comparison of three different volumes of mepivacaine in axillary plexus block using multiple nerve stimulation. Br J Anaesth. 2003 Oct;91(4):519-24. doi: 10.1093/bja/aeg215.
- Background: PubMed 22664978Fredrickson MJ, Abeysekera A, White R. Randomized study of the effect of local anesthetic volume and concentration on the duration of peripheral nerve blockade. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):495-501. doi: 10.1097/AAP.0b013e3182580fd0.
- Background: PubMed 20034967Latzke D, Marhofer P, Zeitlinger M, Machata A, Neumann F, Lackner E, Kettner SC. Minimal local anaesthetic volumes for sciatic nerve block: evaluation of ED 99 in volunteers. Br J Anaesth. 2010 Feb;104(2):239-44. doi: 10.1093/bja/aep368. Epub 2009 Dec 23.
- Background: PubMed 24809480Ecoffey C, Oger E, Marchand-Maillet F, Cimino Y, Rannou JJ, Beloeil H; SOS French Regional Anaesthesia Hotline. Complications associated with 27 031 ultrasound-guided axillary brachial plexus blocks: a web-based survey of 36 French centres. Eur J Anaesthesiol. 2014 Nov;31(11):606-10. doi: 10.1097/EJA.0000000000000063.
- Background: PubMed 21148659Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.
- Background: PubMed 16857551Hebl JR. The importance and implications of aseptic techniques during regional anesthesia. Reg Anesth Pain Med. 2006 Jul-Aug;31(4):311-23. doi: 10.1016/j.rapm.2006.04.004. No abstract available.
- 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.
José Aguirre, PD Dr Med principal investigator
Der Balgrist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dominant Arm and Non-dominant arm in people with Regional Anesthesia, run by Jose Aguirre at 1 site in Switzerland.
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 8 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 22 May 2020. 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 Switzerland. 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?
Correlation between nerve cross-section and time to complete sensory block of a nerve (time frame: Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797235, which also lists 14 linked publications.
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 22 May 2020.