Nerve BlockNCT03667898
Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
A study testing Lumbar plexus block using NTT and Lumbar plexus block without NTT in people with Nerve Block, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Block
- What is being tested?
- Lumbar plexus block using NTT and Lumbar plexus block without NTT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNorway
- Study dates
- 8 Oct 2018to 30 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Volunteers that have given informed written consent
Who cannot join
- BMI < 18 kg/m2
- BMI > 35 kg/m2
- Body weight > 95 kg
- Volunteers that cannot cooperate during the examination
- Volunteers that do not speak or understand Norwegian language
- Volunteers with neurologic disease, nerve- or vascular impairment
Show all 15Show fewer
- Volunteers with known coagulopathy
- Volunteers that are allergic to Lidocaine or other local anaesthetic agents
- Medications at the investigators discretion
- Volunteers with concomitant medical treatments interfering with PNB treatment
- Skin disease or infection affecting the whole-body surface or within the area of examination
- Any reason why, in the opinion of the investigators, the volunteer should not participate
- Subject participates in a potentially confounding drug or device trial during the course of the study
- Pregnancy and lactation period
- Women of childbearing potential who do not use an effective and secure method for birth control
Trial locations and contacts
1 site in 1 country.
About this study
In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. 27 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.
- Conditions
- Nerve Block
- Being tested
- Lumbar plexus block using NTT, Lumbar plexus block without NTT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar plexus block using NTTProcedure or surgery
An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
Lumbar plexus block without NTTProcedure or surgery
An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.
| Study group | Role | What they receive |
|---|---|---|
| Active needle tip tracking | Experimental | A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block. Receives: Procedure: Lumbar plexus block using NTT |
| Inactive needle tip tracking | Other | No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block. Receives: Procedure: Lumbar plexus block without NTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance time
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
Measured: During peripheral nerve block procedure
Secondary outcomes (9)
Distance travelled by needling hand
Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Measured: During peripheral nerve block procedure
Distance travelled by probe hand
Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Measured: During peripheral nerve block procedure
Number of intended movements (needling hand)
Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Measured: During peripheral nerve block procedure
Number of intended movements (probe hand)
Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Measured: During peripheral nerve block procedure
Block success
A sensory block is defined as successful when there is analgesia (no sensation for touch) or anaesthesia (no sensation at all) involving all five nerves distal to the elbow
Measured: 30 minutes after peripheral nerve block procedure
Block onset time
Block onset time is defined as the time between the end of LA injection and development of a successful sensory block
Measured: Within 30 minutes after peripheral nerve block procedure
Block duration
Block duration is the time from the end of LA injection until at least one of the nerves involved in the sensory block has recovered
Measured: Within 240 minutes after peripheral nerve block procedure
Quantified discomfort during block performance
The participants are asked about discomfort during the block procedure using a numeric rating scale (scale range 0 - 10; 0 = no discomfort; 10 = worst discomfort imaginable)
Measured: Immediately after peripheral nerve block procedure
Confidence in block success
The anaesthetist is asked if he expects the block to be successful using a numeric rating scale (scale range 0 - 10; 0 = block success unlikely; 10 = block success very likely)
Measured: Immediately after peripheral nerve block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start8 Oct 2018
- Primary completion26 Oct 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems, B. Braun Melsungen AG
- Responsible party
- Principal investigator, Axel Rudolf Sauter, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667898
- Sponsor's protocol ID
- 2018/1100
- Status last verified
- Dec 2018
- First submitted
- 7 Sep 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
- ClinicalTrials.gov ID
- NCT03667898
- Acronym / sponsor ID
- 2018/1100
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Philips Medical Systems, B. Braun Melsungen AG
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Sep 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.
In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. 27 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active needle tip tracking | Experimental | Procedure: Lumbar plexus block using NTTA needle tip tracking system is used when performing an ultrasound guided lumbar plexus block. |
| Inactive needle tip tracking | Other | Procedure: Lumbar plexus block without NTTNo needle tip tracking system is used when performing an ultrasound guided lumbar plexus block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Volunteers that have given informed written consent
Key exclusion criteria (15 listed)
- BMI < 18 kg/m2
- BMI > 35 kg/m2
- Body weight > 95 kg
- Volunteers that cannot cooperate during the examination
- Volunteers that do not speak or understand Norwegian language
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 |
|---|---|---|
| Lumbar plexus block using NTTAn lumbar plexus block is performed using ultrasound guidance with needle tip tracking. | Procedure or surgery | Active needle tip tracking |
| Lumbar plexus block without NTTAn lumbar plexus block is performed using ultrasound guidance without needle tip tracking. | Procedure or surgery | Inactive needle tip tracking |
Primary outcome
Performance time
Time frame: During peripheral nerve block procedure
Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection
9 secondary outcomes
Distance travelled by needling hand
Time frame: During peripheral nerve block procedure
Distance travelled by probe hand
Time frame: During peripheral nerve block procedure
Number of intended movements (needling hand)
Time frame: During peripheral nerve block procedure
Number of intended movements (probe hand)
Time frame: During peripheral nerve block procedure
Block success
Time frame: 30 minutes after peripheral nerve block procedure
Block onset time
Time frame: Within 30 minutes after peripheral nerve block procedure
Block duration
Time frame: Within 240 minutes after peripheral nerve block procedure
Quantified discomfort during block performance
Time frame: Immediately after peripheral nerve block procedure
Confidence in block success
Time frame: Immediately after peripheral nerve block procedure
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 12 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar plexus block using NTT and Lumbar plexus block without NTT in people with Nerve Block, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 15 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 12 Dec 2018. 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 Norway. 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?
Performance time (time frame: During peripheral nerve block procedure). 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 12 Dec 2018.