Orthopedic SurgeryNCT03430453
Monitoring of Intensity of Stimulation and Injection Pressure in US Guided Peripheral Nerve Block According to Anatomic Needle Type Position
A study testing Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade in people with Orthopedic Surgery, run by University Hospital, Montpellier at 9 sites in France.
Trial summary
The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 9 sitesFrance
- Study dates
- 1 May 2012to 31 Dec 2017
- 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
- Patient who need a Orthopedic surgery
- Peripheral nerve block
- More or equal to 18 years old
- I to III ASA classification status
- Benefit from an insurance regimen
Who cannot join
- severe coagulopathy
- allergy to local anesthetics
- local cutaneous lesion
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
University Hospital of Annecy
Annecy
University hospital of Bordeaux
Bordeaux
University hospital of Clermont-Ferrand
Clermont-Ferrand
University Hospital of Colmar
Colmar
University hospital of limoges
Limoges
University hospital of Marseille
Marseille
University Hospital of Montpellier
Montpellier, 34295
University hospital of Nice
Nice
University Hospital of Reims
Reims
About this study
Official title: Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position
The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade
Read the detailed description
The needle is placed at the target under ultrasound guidance the nerve stimulator is turned on and the intensity increased until motor response is observed the Minimum Intensity Observation (MIS) is recorded before injection of local anesthetic
- Conditions
- Orthopedic Surgery
- Being tested
- Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade
- Keywords
- Regional Anesthesia, Ultrasound guidance, Nerve stimulation, Orthopedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockadeProcedure or surgery
A needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. The Minimal Intensity of Stimulation is recorded before injection of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Patient with ultrasound guided peripheral nerve blockade | Experimental | A needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. Receives: Procedure: Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Minimum Intensity Stimulation
Minimal Intensity Stimulation (MIS) was measured Using a specific nerve stimulator (modified HNS 12 B. BRAUN, Melsungen, Germany) ; the value are noted in mA. [0- 1.5].
The time frame is only related to procedure of PNB. In other term, the period of assessment should be estimated between 2 minutes and 20 minutes.
Measured: estimated between 2 minutes and 20 minutes.
Secondary outcomes (1)
tissure pressure at the target
Tissue pressure at the target was measured Using a specific pressure sensor (compuflow pump Milestone Scientific, Livingston, NJ, USA) ; the value are noted in mm Hg. [0- 900].
from beginning to end of ultrasound guided peripheral nerve blockade
Measured: estimated between 2 minutes and 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 May 2012
- Primary completion5 Jun 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430453
- Sponsor's protocol ID
- UF8924
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2015
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.
PubMed 33323786Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.
PubMed 32791158
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position
- ClinicalTrials.gov ID
- NCT03430453
- Acronym / sponsor ID
- UF8924
- Conditions
- Orthopedic Surgery
- Keywords
- Regional Anesthesia, Ultrasound guidance, Nerve stimulation, Orthopedic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 13 Feb 2018 (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 purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade
Detailed description
The needle is placed at the target under ultrasound guidance the nerve stimulator is turned on and the intensity increased until motor response is observed the Minimum Intensity Observation (MIS) is recorded before injection of local anesthetic
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with ultrasound guided peripheral nerve blockade | Experimental | Procedure: Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockadeA needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who need a Orthopedic surgery
- Peripheral nerve block
- More or equal to 18 years old
- I to III ASA classification status
- Benefit from an insurance regimen
Key exclusion criteria (3 listed)
- severe coagulopathy
- allergy to local anesthetics
- local cutaneous lesion
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 |
|---|---|---|
| Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockadeA needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. The Minimal Intensity of Stimulation is recorded before injection of local anesthetic | Procedure or surgery | Patient with ultrasound guided peripheral nerve blockade |
Primary outcome
Measurement of Minimum Intensity Stimulation
Time frame: estimated between 2 minutes and 20 minutes.
Minimal Intensity Stimulation (MIS) was measured Using a specific nerve stimulator (modified HNS 12 B. BRAUN, Melsungen, Germany) ; the value are noted in mA. [0- 1.5]. The time frame is only related to procedure of PNB. In other term, the period of assessment should be estimated between 2 minutes and 20 minutes.
1 secondary outcome
tissure pressure at the target
Time frame: estimated between 2 minutes and 20 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 13 Feb 2018.
- Derived from this study: PubMed 33323786Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.
- Derived from this study: PubMed 32791158Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade in people with Orthopedic Surgery, run by University Hospital, Montpellier at 9 sites in France.
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 5 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: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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?
Measurement of Minimum Intensity Stimulation (time frame: estimated between 2 minutes and 20 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 NCT03430453, which also lists 2 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 13 Feb 2018.