Simulation-Based Team Training for Management of Local Anesthetic Systemic Toxicity (LAST) in Non-Anesthesiologist Surgical Residents (LAST)

March 10, 2026 updated by: Faruk Cicekci, Selcuk University

Evaluation of the Effectiveness of a Local Anesthetic Systemic Toxicity (LAST) Knowledge Training Program for Non-Anesthesiologist Surgical Residents

This randomized controlled trial evaluates the effectiveness of a simulation-based multidisciplinary team training program on the management of Local Anesthetic Systemic Toxicity (LAST) among non-anesthesiologist surgical residents. Guided by Kirkpatrick's evaluation model, the study investigates improvements in knowledge, technical and non-technical skills, and the retention of these competencies one month after training

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Local Anesthetic Systemic Toxicity (LAST) is a rare but potentially life-threatening complication of regional anesthesia. Advances in ultrasound-guided blocks have reduced its incidence, yet LAST remains a major concern due to severe cardiovascular and neurological risks. The American Society of Regional Anesthesia and Pain Medicine (ASRA) recommends early lipid emulsion therapy and emphasizes proper training. Simulation-based multidisciplinary training provides a dynamic and immersive experience, improving both technical and behavioral skills. This trial applies Kirkpatrick's four-level model (reaction, learning, behavior, results) to assess the training program. Primary endpoint: improvement in knowledge test scores. Secondary endpoints: OSCE performance, satisfaction, and key performance indicators related to simulated LAST management.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Konya, Turkey (Türkiye), 42250
        • Selcuk Universitesi, School of Medicine, Anesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Surgical residents (General Surgery, Orthopedics, Obstetrics & Gynecology, Dentistry) on active rotation at Selçuk University Faculty of Medicine.
  2. Voluntary participation with written informed consent.
  3. No prior comprehensive LAST training in the last 12 months.

Exclusion Criteria:

  1. Prior comprehensive LAST training or instructor experience in the last 12 months.
  2. Anesthesiology residents or specialists.
  3. Unable to complete follow-up due to rotation change or leave.
  4. Declining or withdrawing consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Structured Training Group
Experimental: Structured Training Group - Local Anesthetic Systemic Toxicity (LAST) pretest application, then Kirkpatrick-based program (2-3 hours; theoretical + simulation/OSCE). Includes theoretical (pathophysiology, risk factors, prevention, lipid therapy algorithm) and practical modules (simulation scenario, OSCE checklist, structured feedback). Local Anesthetic Systemic Toxicity (LAST) lasttest application It is assumed that a higher test score indicates a higher level of knowledge on the topic.
Behavioral: Education
Local Anesthetic Systemic Toxicity (LAST); Simulation-based Education; Perioperative Training
Experimental: Control
Control: Standard Training Group (Wait-list Control) - Routine anesthesia training during standard rotation. Structured training provided after study completion.
Behavioral: Education
Local Anesthetic Systemic Toxicity (LAST); Simulation-based Education; Perioperative Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge improvement (Learning outcome)
Time Frame: Baseline (Day 0) to immediately post-training.
Local Anesthetic Systemic Toxicity (LAST) Knowledge Level and Awareness Test Change in 25-item multiple-choice test score (Δ = post-test - pre-test) Scoring: 0-25. It is accepted that as the score obtained for the test increases, the level of knowledge about the subject increases.
Baseline (Day 0) to immediately post-training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • farukcicekci9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be made available from the corresponding author upon reasonable request after publication of the article.

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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