NCT01583010

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

April 20, 2012

Last Update Submit

April 20, 2012

Conditions

AnaesthesiaTrauma

Keywords

ultrasound guided regional anaesthesia needle visualization

Outcome Measures

Primary Outcomes (1)

  • Time of needle visibilty in ultrasound-image

    Measure is given in percentage of procedure time

    At time of ultrasound guided regional anaesthesia

Secondary Outcomes (2)

  • Procedure time

    At time of ultrasound guided regional anaesthesia

  • Angle of needle insertion

    At time of ultrasound guided regional anaesthesia

Study Arms (2)

Standard Treatment Group

NO INTERVENTION

Patients receiving ultrasound guided regional anaesthesia without using Advanced Needle Visualization Technology(R)

ANV ® Group

ACTIVE COMPARATOR

Patients receiving ultrasound guided regional anaesthesia with using Advanced Needle Visualization Technology(R)

Device: ANV(R)

Interventions

ANV(R)DEVICE

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

Also known as: SonoSite M-Turbo Mbe
ANV ® Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21425515BACKGROUND

  • 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.

    PMID: 17961844BACKGROUND

  • 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.

    PMID: 16430568BACKGROUND

  • 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.

    PMID: 19258968BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Reinhard Hahn, Univ. Lektor Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhard Hahn, Univ. Lektor Dr.

CONTACT

+431404004100reinhard.hahn@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

December 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

AU(1)