NCT03516058

Brief Summary

The purpose of this study was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model. The residents filled out a questionnaire before and after the training session. The questionnaires consisted of knowledge including ultrasound anatomy and block technique, comfort, confidence, and axiety levels for the TAP block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

April 23, 2018

Last Update Submit

February 8, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • impact of a simulation-based ultrasound-guided TAP block training session_Comfort level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 1 week after training session

  • impact of a simulation-based ultrasound-guided TAP block training session_Comfort level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 2 months after training session

  • impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 1 week after training session

  • impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 2 months after training session

  • impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 1 week after training session

  • impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level

    5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high

    within 2 months after training session

Interventions

Participating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session. The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training.

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants included second-year residents, third-year residents who can participate in the anesthesiology simulation training.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

May 1, 2018

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

February 11, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations