Safety of Regional Anesthesia in Ukraine: the Survey

Sponsor
Bogomolets National Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05478629
Collaborator
(none)
182
1
17.8
10.2

Study Details

Study Description

Brief Summary

The common using of ultrasound navigation makes an opportunity to develop the regional anesthesia. Regional anesthesia reduces the length of stay in the hospital, reduces the intensity of perioperative pain and decrease opioid using. But systemic toxicity of local anesthetics (LAST) is a significant problem. Prevalence of LAST in Europe range from 0.04 to 1.8 cases per 100 thousand local anesthesia. No similar studies have been provided in Ukraine before, and there are no statistics on the LAST epidemiology. Goal of this survey - evaluation of the prevalence of LAST, the safety of regional anesthesia in Ukraine.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey

Detailed Description

The survey was conducted from October 2021-February 2022 by filling out a standard Google form. The survey design was approved by Bogomolets National Medical University ethical committee (protocol #151 on 25 October 2021). All participants sign the informed consent form before filling out the questionnaire. The link to the survey was published on the Ukrainian Association of Anesthesiologists webpage and Facebook page. The survey link is https://aaukr.org/opytuvannya-shhodo-vypadkiv-toksychnosti-mistsevyh-anestetykiv/.

To conduct the survey, we formed a questionnaire of 14 items. We studied the literature that describes in detail the methods of providing similar surveys [5, 6].

The questionnaire was designed to ensure sufficient collection of data from respondents on demographics, awareness of the LAST guidelines, the availableness of ultrasound navigation, and of preparations of fat emulsions in their departments. Also, we made an accent on the presence of safety protocols, using a check-list of LAST before every regional anesthesia. And we've investigated communication in the hospital if LAST or another critical incident occurs in the OR.

The structure of the questionnaire makes doctors an opportunity to fill it in a short time. We also provided respondents with more descriptive and detailed answers to some questions if they wished. The questionnaire is available in the supplemental material. Multiple options to answer are required to fill, other questions were free to answer. The survey was provided in Ukrainian. Only practicing anesthesiologists, heads of departments, practicing Ph.D. students and professors were invited to take part in the survey.

Statistical analysis. We've imported the results of the survey into Microsoft Excel for continuous analysis. Simple descriptive statistics were used.

Study Design

Study Type:
Observational
Actual Enrollment :
182 participants
Observational Model:
Ecologic or Community
Time Perspective:
Retrospective
Official Title:
National Audit of the Safety of Regional Anesthesia in Hospitals of Ukraine
Actual Study Start Date :
Oct 25, 2021
Actual Primary Completion Date :
Feb 23, 2022
Anticipated Study Completion Date :
Apr 20, 2023

Outcome Measures

Primary Outcome Measures

  1. Prevalence of the ultrasound navigation, LAST protocols [10/01/2021-02/23/2022]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

practicing anesthesiologists

Exclusion Criteria:

working not in Ukraine

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bogomolets NMU Kyiv Ukraine

Sponsors and Collaborators

  • Bogomolets National Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kateryna Bielka, Associate Professor, Bogomolets National Medical University
ClinicalTrials.gov Identifier:
NCT05478629
Other Study ID Numbers:
  • 151
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kateryna Bielka, Associate Professor, Bogomolets National Medical University

Study Results

No Results Posted as of Jul 28, 2022