Improvement of Needle Visibility in Ultrasound Guided Regional Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Reinhard Hahn, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01583010
First received: April 20, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Anaesthesia
Trauma
Device: ANV(R)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improvement of Needle Visibility in In-line Regional Anaesthesia by "Advanced Needle Visualization Technology ®"

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Time of needle visibilty in ultrasound-image [ Time Frame: At time of ultrasound guided regional anaesthesia ] [ Designated as safety issue: No ]
    Measure is given in percentage of procedure time


Secondary Outcome Measures:
  • Procedure time [ Time Frame: At time of ultrasound guided regional anaesthesia ] [ Designated as safety issue: No ]
    Duration of placement of the ultrasound probe up to needle-removal out of the skin.

  • Angle of needle insertion [ Time Frame: At time of ultrasound guided regional anaesthesia ] [ Designated as safety issue: No ]
    Measurement of puncture-angle between skin an needle in the ultrasound-image.


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Treatment Group
Patients receiving ultrasound guided regional anaesthesia without using Advanced Needle Visualization Technology(R)
Active Comparator: ANV ® Group
Patients receiving ultrasound guided regional anaesthesia with using Advanced Needle Visualization Technology(R)
Device: ANV(R)

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

Other Name: SonoSite M-Turbo Mbe

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients get excluded if they refused or are unable to give consent by other reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583010

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

Locations
Austria
Department of Anesthesia, Intensive Care Medicine and Pain Therapy, Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Reinhard Hahn, Univ. Lektor Dr.    +431404004100    reinhard.hahn@meduniwien.ac.at   
Contact: Kettner Stephan, Prof. Dr.    +431404004100    stephan.kettner@meduniwien.ac.at   
Principal Investigator: Reinhard Hahn, Univ. Lektor Dr.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Reinhard Hahn, Univ. Lektor Dr. Medical University of Vienna
  More Information

Publications:
Responsible Party: Reinhard Hahn, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01583010     History of Changes
Other Study ID Numbers: EK572/2011
Study First Received: April 20, 2012
Last Updated: April 20, 2012
Health Authority: Austria: Ethikkommission
Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Medical University of Vienna:
ultrasound guided regional anaesthesia needle visualization

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014