Regional Anesthesia MorbidityNCT05478629
Safety of Regional Anesthesia in Ukraine: the Survey
An observational study of Regional Anesthesia Morbidity, run by Bogomolets National Medical University at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity
- What is being tested?
- Survey
- How many people
- 182 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Oct 2021to 20 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Practicing anesthesiologists, chiefs of the ICU, teaching assistants
Who may be able to join
- practicing anesthesiologists
Who cannot join
- working not in Ukraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Audit of the Safety of Regional Anesthesia in Hospitals of Ukraine
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.
Read the 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.
- Conditions
- Regional Anesthesia Morbidity
- Being tested
- Survey
- Keywords
- regional anesthesia, LAST, Patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Questioning through google forms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the ultrasound navigation, LAST protocols
Measured: 10/01/2021-02/23/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start25 Oct 2021
- Primary completion23 Feb 2022
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateryna Bielka, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478629
- Sponsor's protocol ID
- 151
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Audit of the Safety of Regional Anesthesia in Hospitals of Ukraine
- ClinicalTrials.gov ID
- NCT05478629
- Acronym / sponsor ID
- 151
- Conditions
- Regional Anesthesia Morbidity
- Keywords
- regional anesthesia, LAST, Patient safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Practicing anesthesiologists, chiefs of the ICU, teaching assistants
Key inclusion criteria (1 listed)
- practicing anesthesiologists
Key exclusion criteria (1 listed)
- working not in Ukraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyQuestioning through google forms | Other | – |
Primary outcome
Prevalence of the ultrasound navigation, LAST protocols
Time frame: 10/01/2021-02/23/2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- The survey linkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity, run by Bogomolets National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of the ultrasound navigation, LAST protocols (time frame: 10/01/2021-02/23/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.