Safety of Regional Anesthesia in Ukraine: the Survey

Regional Anesthesia Morbidity Clinical Trial

Official title:

National Audit of the Safety of Regional Anesthesia in Hospitals of Ukraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05478629
• Other study ID #: 151
• Status: Active, not recruiting
• Start date: October 25, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: July 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: April 20, 2023
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

practicing anesthesiologists

Exclusion Criteria:

working not in Ukraine

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Other:
• Survey
Questioning through google forms

Locations

Country	Name	City	State
Ukraine	Bogomolets NMU	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the ultrasound navigation, LAST protocols		10/01/2021-02/23/2022

External Links

•   The survey link