NCT02370472

Brief Summary

The use of Ultrasound Guided Regional Anaesthesia (USRA) has increased over the last decade. Theoretically, ultrasound imaging may increase efficacy and safety by allowing visualization of the needle pathway and local anaesthetic spread around the nerve. In addition to knowledge of anatomy and general principles of ultrasonography, USRA requires learning new skills such as image interpretation, needle-beam alignment, and needle trajectory tracking. The hand-eye coordination required during needle advancement requires practice to master because the needle must be properly aligned with the ultrasound probe in order to maintain the needle path in the beam at all times. Adding to the difficulty, hand and needle movements can occur in three axes, but an ultrasound image is seen in only two dimensions. Since the ability to acquire the necessary skills to perform USRA is subjective and not yet validated, it is difficult to recommend a single, effective training pathway. Currently, the only method of supervised training before performing an USRA procedure on an actual patient involves practicing needle insertion in a phantom or cadaver. Studies assessing the impact of learning using these methods are lacking. It is possible that some practitioners may choose alternative one-off learning methods. Such methods are not standardized and are thus difficult to evaluate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

February 18, 2015

Last Update Submit

March 1, 2018

Conditions

Keywords

UltrasoundImageLearning ToolUltrasound Guide ProceduresSimulated Setting

Outcome Measures

Primary Outcomes (1)

  • Needle image accuracy score difference

    The experimental group was allowed to practice the same pre-test task using the same ultrasound machine and phantom model. On a single computer screen, they were able to visualise their hand and needle movements along with the position of the ultrasound probe. The control group was allowed to practice the same pre-test task using the same ultrasound machine and phantom model but without the added visual aid. Both groups were allowed to practice their pre-test tasks for a maximum of 30 minutes

    30 minutes

Study Arms (2)

control group

NO INTERVENTION

complete pre-study form 10 minute familiarization time with equipment view video demonstration of task perform task 3 times assessed using scoring form - pretest assigned to group practice task again for 30 minutes proficiency noted final evaluation

Experimental

EXPERIMENTAL

complete pre-study form 10 minute familiarization time with equipment view video demonstration of task perform task 3 times assessed using scoring form - pretest assigned to group practice task again for 30 minutes - subjects will use tool developed using cameras and a computer to visualize hand and needle movements as well as the position of the transducers along with the image from the ultrasound on a computer screen proficiency belief noted final evaluation

Other: tool developed using cameras and a computer

Interventions

cameras allowing subject to be able to visualize hand and needle movements as well s the position of the transducers along with the image from the ultrasound on a computer screen

Experimental

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health Care professional

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

  • Sites BD, Chan VW, Neal JM, Weller R, Grau T, Koscielniak-Nielsen ZJ, Ivani G. The American Society of Regional Anesthesia and Pain Medicine and the European Society of Regional Anaesthesia and Pain Therapy joint committee recommendations for education and training in ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S74-80. doi: 10.1097/AAP.0b013e3181d34ff5.

  • Ramlogan R, Manickam B, Chan VW, Liang L, Adhikary SD, Liguori GA, Hargett MJ, Brull R. Challenges and training tools associated with the practice of ultrasound-guided regional anesthesia: a survey of the American society of regional anesthesia and pain medicine. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):224-6. doi: 10.1097/AAP.0b013e3181c69c94. No abstract available.

  • Adhikary SD, Hadzic A, McQuillan PM. Simulator for teaching hand-eye coordination during ultrasound-guided regional anaesthesia. Br J Anaesth. 2013 Nov;111(5):844-5. doi: 10.1093/bja/aet364. No abstract available.

  • Smith HM, Kopp SL, Jacob AK, Torsher LC, Hebl JR. Designing and implementing a comprehensive learner-centered regional anesthesia curriculum. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):88-94. doi: 10.1097/AAP.0b013e31819e734f. No abstract available.

Study Officials

  • Sanjib Adhikary, MB BS MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor , Director Acute Pain, Regional Anesthesia/Orthopedics

Study Record Dates

First Submitted

February 18, 2015

First Posted

February 25, 2015

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 2, 2018

Record last verified: 2018-03

Locations