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AnaesthesiaNCT01583010

Improvement of Needle Visibility in Ultrasound Guided Regional Anaesthesia

A study testing ANV(R) in people with Anaesthesia and Trauma, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Needle tip visualization, although fundamental to the safety and efficacy of ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is most marked at steep insertion angles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anaesthesia, Trauma
What is being tested?
ANV(R)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteAustria
Study dates
Dec 2011to May 2012
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

  • Patients, who give consent and undergo a femoral or supraclavicular nerve block.

Who cannot join

  • Patients get excluded if they refused or are unable to give consent by other reasons

Trial locations and contacts

1 site in 1 country.

Reinhard Hahn, Univ. Lektor Dr. contact

+431404004100

reinhard.hahn@meduniwien.ac.at

Austria1 site, 1 recruiting

  • Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Medical University Vienna

    Vienna, State of Vienna, 1090

    Reinhard Hahn, Univ. Lektor Dr., +431404004100, reinhard.hahn@meduniwien.ac.at

    Kettner Stephan, Prof. Dr., +431404004100, stephan.kettner@meduniwien.ac.at

    Recruiting

Other trials in Austria

About this study

Official title: Improvement of Needle Visibility in In-line Regional Anaesthesia by "Advanced Needle Visualization Technology ®"

Needle tip visualization, although fundamental to the safety and efficacy of ultrasound-guided regional anesthesia (UGRA), can be extremely challenging. This problem is most marked at steep insertion angles. Studies in patients with UGRA demonstrate that echogenic needle designs have the potential to offer improved visibility and accuracy.

Our study pursues another approach. We use (for differentiation) echogenic nerve block needles with ANV®, a new SonoSite software-upgrade (Advanced Needle Visualization Technology®). We will compare UGRA with ANV® against standard UGRA without using this SonoSite software-upgrade. Patients undergoing femoral, supraclavicular or other nerve blocks as part of their routine anesthetic management are included.

This work represents the first randomized controlled double blinded clinical trial of ANV® in patients undergoing UGRA. We hypothesize, that we can decrease the time without needle visualization (Loss of needle time in percentage of procedure time) during in-line regional anaesthesia. Furthermore we will record quality of visibility, duration of procedure and insertion angle of the needle.

Read the detailed description

Patients scheduled to undergo surgery with femoral (n = 50) and supraclavicular (n=50) anaesthesia (100 blocks total) gets included in this study. These 50 patients will be randomized equally using sealed opaque envelopes to two parallel groups: standard treatment UGRA (n=25) and SonoSites ANV® (n= 25) UGRA.

An experienced anaesthesiologist from department of anaesthesiology, general intensive care and pain medicine will perform UGRA. Because of safety reasons and best assessment of needle visibility all UGRA in this study are going to performed with in-plane ultrasound technique. Needle length and gauge are standardized.

The ultrasound imaging of each nerve block gets recorded onto a DVD for analysis. Recording of performed UGRA will start with placement of ultrasound probe and will finish with needle leaving the skin (procedure time), get stored, checked to exclude technical failures and analysed with a one second discrimination by two blinded observers for needle visibility. All information indicating ANV®-status on ultrasound image will be deleted. Hence for procedure and following analysis we will ensure that patient and the objective observer are blinded.

Images with full needle visibility will be related to images without needle visibility. Time of needle visibility will be described in percent of procedure time.

Enduring visualization of complete needle in ultrasound beam won't be given during the whole procedure. For differentiation of complete needle visibility, partial or no visibility in in-plane UGRA, we will use needles with ultrasound visible marks (echogenic needles). If the objective observers will visualize all 3 marks and pole of the needle in ultrasound-image, needle is completely in-plane and visible for analysis. For partial visibility of marks we will use a needle visibility grading dependent to number of visible marks (One mark = poor visibility, two marks = middle visibility, three marks=good visibility). If there won't be visible marks in ultrasound image, needle is in absence and gets evaluated as "not visible".

Dependent to position of anatomic target structure each nerve block will need a different angle of needle insertion. This measured angle will be used to compare times of needle visibility dependent to insertion angle of the needle. Significant differences may appear especially in steep angles of needle.

In this study we will use Naropin® (Ropivaciane, 7.5mg/ml) as local anaesthetic for all UGRA.

Conditions
Anaesthesia, Trauma
Being tested
ANV(R)
Keywords
ultrasound guided regional anaesthesia needle visualization
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANV(R)Device

    Also called SonoSite M-Turbo Mbe

    Device: Advanced Needle Visualization Technology ®

    Software update for SonoSites M-Turbo® and S-series™ ultrasound systems with enhanced 15-20Mhz ultrasound probe.

    Arms: ANV ® Group

Study groups in NCT01583010
Study groupRoleWhat they receive
Standard Treatment GroupNo interventionPatients receiving ultrasound guided regional anaesthesia without using Advanced Needle Visualization Technology(R)
ANV ® GroupActive comparatorPatients receiving ultrasound guided regional anaesthesia with using Advanced Needle Visualization Technology(R)
Receives: Device: ANV(R)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time of needle visibilty in ultrasound-image

    Measure is given in percentage of procedure time

    Measured: At time of ultrasound guided regional anaesthesia

Secondary outcomes (2)

  1. Procedure time

    Duration of placement of the ultrasound probe up to needle-removal out of the skin.

    Measured: At time of ultrasound guided regional anaesthesia

  2. Angle of needle insertion

    Measurement of puncture-angle between skin an needle in the ultrasound-image.

    Measured: At time of ultrasound guided regional anaesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionMay 2012 (estimated)
  4. Study completionMay 2012 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01583010
Sponsor's protocol ID
EK572/2011
Status last verified
Apr 2012
First submitted
20 Apr 2012
Last updated
23 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • Hebard S, Hocking G. Echogenic technology can improve needle visibility during ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):185-9. doi: 10.1097/aap.0b013e31820d4349.

    PubMed 21425515

  • Maecken T, Zenz M, Grau T. Ultrasound characteristics of needles for regional anesthesia. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):440-7. doi: 10.1016/j.rapm.2007.07.002.

    PubMed 17961844

  • Chapman GA, Johnson D, Bodenham AR. Visualisation of needle position using ultrasonography. Anaesthesia. 2006 Feb;61(2):148-58. doi: 10.1111/j.1365-2044.2005.04475.x.

    PubMed 16430568

  • Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. doi: 10.1016/j.rapm.2008.06.002.

    PubMed 19258968

Questions about this trial

What is this clinical trial studying?

A study testing ANV(R) in people with Anaesthesia and Trauma, run by Medical University of Vienna at 1 site in Austria.

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 1 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: status not confirmed, as of the sponsor's last update on 23 Apr 2012. 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 Austria. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Reinhard Hahn, Univ. Lektor Dr. (+431404004100, reinhard.hahn@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time of needle visibilty in ultrasound-image (time frame: At time of ultrasound guided regional anaesthesia). 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 NCT01583010, which also lists 4 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 23 Apr 2012.

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