NCT07463274

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

September 15, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

September 22, 2025

Last Update Submit

March 10, 2026

Conditions

Keywords

Local anestheticQuestionnairesRegional anesthesiaTeam

Outcome Measures

Primary Outcomes (1)

  • Knowledge improvement (Learning outcome)

    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.

Study Arms (2)

Structured Training Group

EXPERIMENTAL

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

Control

EXPERIMENTAL

Control: Standard Training Group (Wait-list Control) - Routine anesthesia training during standard rotation. Structured training provided after study completion.

Behavioral: Education

Interventions

EducationBEHAVIORAL

Local Anesthetic Systemic Toxicity (LAST); Simulation-based Education; Perioperative Training

ControlStructured Training Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk Universitesi, School of Medicine, Anesthesiology

Konya, 42250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, Parallel Assignment, Prospective, Assessor-blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr

Study Record Dates

First Submitted

September 22, 2025

First Posted

March 11, 2026

Study Start

September 15, 2025

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
1 year

Locations