Anesthesia, LocalNCT03383770
Dual Guidance in Regional Anesthesia
A study testing Regional Anesthesia Touhy and Regional Anesthesia Facet in people with Anesthesia, Local and Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Regional anaesthesia is a frequently used procedure. Currently, blockades are increasingly carried out without nerve stimulation. The risk of nerve lesion is about 3 %. Industrial efforts frequently referred to ultrasound optimisation of the regional anaesthesia cannula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Anesthesia, Anesthesia; Adverse Effect
- What is being tested?
- Regional Anesthesia Touhy and Regional Anesthesia Facet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 5 Feb 2018to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of the written declaration of consent
- Age of at least 18 years
- No participation in another intervention study during participation
Who cannot join
- present contraindication for the application of regional anesthesia and nerve stimulation
- Cardiac pacemaker/AICD (Automated internal cardioverter defibrillator) carrier
- Known allergies to used medicines
- Patients under 18 years of age
- Ineligible patients
- Missing consent
Show all 13Show fewer
- Pregnancy/nursing patients
- Classification of patients into class 4 or higher status according to the American Society of Anesthesiologists
- Existing nerve damage in the target area
- Medically treated diabetes mellitus, alcohol abuse or alcohol abuse in the patient's history (using AUDIT)
- Visibility score of the nerve of 3 or more
- Participation in another intervention study during participation
- Accommodation in an institution on the basis of a court or administrative order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin Campus Charité Mitte
Berlin, Deutschland, 10115
About this study
Official title: Dual Guidance in Regional Anesthesia - Prospective Randomized Study of Needle-nerve Distance in Different Cannulas for Regional Nerve Blockade
Regional anaesthesia is a frequently used procedure. Currently, blockades are increasingly carried out without nerve stimulation. The risk of nerve lesion is about 3 %. Industrial efforts frequently referred to ultrasound optimisation of the regional anaesthesia cannula. In order to optimise patient safety, the benefit of both procedures (stimulation and ultrasound) should be combined and both procedures optimised. In this study, the influence of the needle electrode size on the stimulability of the nerve ischiadicus should be determined.
Read the detailed description
There are various methods of performing regional anesthesia. In recent years, the focus has been on ultrasound-supported regional anaesthesia, and the stimulation methods that were often used in the past were no longer used or used less frequently. The combination of both methods may be an additional safety aspect and can contribute to an improved blocking quality. In addition to the best possible ultrasound quality, an optimal stimulation quality is also required. The investigators plan to carry out dual-guidance blockages of the ischiadic nerve with various regional anaesthesia needles (manufacturer of the used needles: Pajunk Medical Produkte GmbH, Geisingen, Germany; Teleflex Medical GmbH, Kernen, Germany). All regional anaesthesia cannulae are approved for the planned blockades of humans in Germany.
- Conditions
- Anesthesia, Local, Anesthesia, Anesthesia; Adverse Effect
- Being tested
- Regional Anesthesia Touhy, Regional Anesthesia Facet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Anesthesia TouhyProcedure or surgery
The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A touhy cannula is used.
Regional Anesthesia FacetProcedure or surgery
The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A facet cannula is used.
| Study group | Role | What they receive |
|---|---|---|
| Tuohy | Active comparator | After a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia).
A tuohy needle is used. Receives: Procedure: Regional Anesthesia Touhy |
| Facet | Active comparator | After a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia).
A facet needle is used. Receives: Procedure: Regional Anesthesia Facet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound distance
Ultrasound-based measurement of needle-nerve distance during the application of the regional anesthesia of the N. ischiadicus during infragluteal access.
Measured: duration of blockade, an average of 15 minutes
Secondary outcomes (5)
Visibility_1
Ultrasound visibility of needle
Measured: duration of blockade, an average of 15 minutes
Visibility_2
Ultrasound visibility of nerve
Measured: duration of blockade, an average of 15 minutes
Impedance
Impedance measured by nerve stimulator while progressing the needle
Measured: duration of blockade, an average of 15 minutes
Effect_motor
Effectiveness of the motor blockade measured by possible movement of the foot
Measured: duration of surgery and recovery unit, an average of 120 minutes
Effect_sensoric
Effectiveness of the blockade measured by temperature sensibility testing on the food
Measured: duration of surgery and recovery unit, an average of 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start5 Feb 2018
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Model description
- The selection of the puncture cannula for regional anaesthesia is not up to the performing anaesthetist, as is usual in the clinical standard, but is made randomly on the basis of a random list. The blockade is carried out by two anaesthetists experienced in regional anaesthesia, who have the principle of dual control. The ultrasound image acquired during the blockade is recorded in the form of an ultrasound video for subsequent evaluation. The recorded ultrasound videos are stored pseudonymously on the server of the Klinik für Anästhesiologie m. S. operativ Intensivmedizin reported to the data protection department.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jurgen Birnbaum, Charite University, Berlin, Germany
- Investigators
- Jürgen Birnbaum, MD, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383770
- Sponsor's protocol ID
- DUAL
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2017
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Guidance in Regional Anesthesia - Prospective Randomized Study of Needle-nerve Distance in Different Cannulas for Regional Nerve Blockade
- ClinicalTrials.gov ID
- NCT03383770
- Acronym / sponsor ID
- DUAL
- Conditions
- Anesthesia, Local, Anesthesia, Anesthesia; Adverse Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 26 Dec 2017 (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.
Regional anaesthesia is a frequently used procedure. Currently, blockades are increasingly carried out without nerve stimulation. The risk of nerve lesion is about 3 %. Industrial efforts frequently referred to ultrasound optimisation of the regional anaesthesia cannula. In order to optimise patient safety, the benefit of both procedures (stimulation and ultrasound) should be combined and both procedures optimised. In this study, the influence of the needle electrode size on the stimulability of the nerve ischiadicus should be determined.
Detailed description
There are various methods of performing regional anesthesia. In recent years, the focus has been on ultrasound-supported regional anaesthesia, and the stimulation methods that were often used in the past were no longer used or used less frequently. The combination of both methods may be an additional safety aspect and can contribute to an improved blocking quality. In addition to the best possible ultrasound quality, an optimal stimulation quality is also required. The investigators plan to carry out dual-guidance blockages of the ischiadic nerve with various regional anaesthesia needles (manufacturer of the used needles: Pajunk Medical Produkte GmbH, Geisingen, Germany; Teleflex Medical GmbH, Kernen, Germany). All regional anaesthesia cannulae are approved for the planned blockades of humans in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The selection of the puncture cannula for regional anaesthesia is not up to the performing anaesthetist, as is usual in the clinical standard, but is made randomly on the basis of a random list. The blockade is carried out by two anaesthetists experienced in regional anaesthesia, who have the principle of dual control. The ultrasound image acquired during the blockade is recorded in the form of an ultrasound video for subsequent evaluation. The recorded ultrasound videos are stored pseudonymously on the server of the Klinik für Anästhesiologie m. S. operativ Intensivmedizin reported to the data protection department.
| Arm | Type | Receives |
|---|---|---|
| Tuohy | Active comparator | Procedure: Regional Anesthesia TouhyAfter a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia). A tuohy needle is used. |
| Facet | Active comparator | Procedure: Regional Anesthesia FacetAfter a careful disinfection of the puncture site, under sterile conditions and under ultrasonographic control with the application of nerve stimulation (settings: stimulation current primary 2.0 mA with stepwise reduction over 1.0 mA to 0.5 mA, pulse width 0.1 ms, pulse frequency 2 Hz) of the N. ischiadicus blocked by 20 ml ropivacaine 0.75 %. (electrical nerve stimulation and ultrasound) If no motor response can be triggered by stimulation, the closest possible needle-nerve distance is generated at a pulse strength of 1mA and regional anesthesia is performed. (protective nerve stimulation) Subsequently, the transplantation into the supine position and the further procedure specific to the operation (use of other regional procedures in combination or general anaesthesia). A facet needle is used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of the written declaration of consent
- Age of at least 18 years
- No participation in another intervention study during participation
Key exclusion criteria (13 listed)
- present contraindication for the application of regional anesthesia and nerve stimulation
- Cardiac pacemaker/AICD (Automated internal cardioverter defibrillator) carrier
- Known allergies to used medicines
- Patients under 18 years of age
- Ineligible patients
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 |
|---|---|---|
| Regional Anesthesia TouhyThe patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A touhy cannula is used. | Procedure or surgery | Tuohy |
| Regional Anesthesia FacetThe patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A facet cannula is used. | Procedure or surgery | Facet |
Primary outcome
Ultrasound distance
Time frame: duration of blockade, an average of 15 minutes
Ultrasound-based measurement of needle-nerve distance during the application of the regional anesthesia of the N. ischiadicus during infragluteal access.
5 secondary outcomes
Visibility_1
Time frame: duration of blockade, an average of 15 minutes
Visibility_2
Time frame: duration of blockade, an average of 15 minutes
Impedance
Time frame: duration of blockade, an average of 15 minutes
Effect_motor
Time frame: duration of surgery and recovery unit, an average of 120 minutes
Effect_sensoric
Time frame: duration of surgery and recovery unit, an average of 120 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 4 Feb 2022.
- 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.
Jürgen Birnbaum, MD, PhD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Anesthesia Touhy and Regional Anesthesia Facet in people with Anesthesia, Local and Anesthesia, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 13 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 4 Feb 2022. 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 Germany. 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?
Ultrasound distance (time frame: duration of blockade, an average of 15 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 4 Feb 2022.