Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline

NCT ID: NCT04029610

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2020-12-01

Brief Summary

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Goals: 1. To check for frequency and type of arrhythmia in patients undergoing a medical procedure under local anesthesia 2. To examine whether the addition of adrenaline to local anesthesia affects the incidence of arrhythmias

Detailed Description

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Rationale: Determining the frequency and type of arrhythmia will help determine the need for monitoring and the type of monitoring required during procedures under local anesthesia.

Patients will undergo the prescribed medical procedure using local anesthesia. Patients will be randomized into two groups: Group 1 - Local anesthesia of lidocaine and arterial blockage on the arm; Group 2 - Local anesthesia with lidocaine and adrenalin.

The amount and type of anesthetic used shall be recorded. In addition to the routine monitoring performed today (use of non-invasive blood pressure gauge and oxygen saturation), the patients will be connected to a cardiac holter monitor prior to the start of the surgical procedure and until they are released from the recovery room. Upon completion of the monitoring, the results of the holter test will be transmitted to the electrophysiology unit and analyzed to detect arrhythmias. There will be a registration of side effects reported by patients, which can result from arrhythmias (palpitations, dizziness, fainting, CPR). In patients in whom arrhythmias are detected, the type of arrhythmia and if it was accompanied by clinical symptoms will be recorded.

Conditions

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Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Local anesthesia of lidocaine and arterial blockage on the arm

Local anesthesia of lidocaine and arterial blockage on the arm

Group Type ACTIVE_COMPARATOR

lidocaine and arterial blockage

Intervention Type DRUG

lidocaine and arterial blockage

Local anesthesia with lidocaine and adrenalin

Local anesthesia with lidocaine and adrenalin

Group Type EXPERIMENTAL

Local anesthesia with lidocaine and adrenalin.

Intervention Type PROCEDURE

Local anesthesia with lidocaine and adrenalin.

lidocaine and adrenalin

Intervention Type DRUG

lidocaine and adrenalin

Interventions

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Local anesthesia with lidocaine and adrenalin.

Local anesthesia with lidocaine and adrenalin.

Intervention Type PROCEDURE

lidocaine and adrenalin

lidocaine and adrenalin

Intervention Type DRUG

lidocaine and arterial blockage

lidocaine and arterial blockage

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients who undergo hand surgery using local anesthesia at Assuta Ashdod Hospital

Exclusion Criteria

* Patients with a known medical history of cardiac arrhythmia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Uri farkash

OTHER

Sponsor Role lead

Responsible Party

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Uri farkash

Head, Hand Surgery Unit, Assuta Ashdod University Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Uri Farkash, MD

Role: PRINCIPAL_INVESTIGATOR

Head, Hand Surgery Unit, Assuta Ashdod Hospital

Locations

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Assuta Ashdod Hospital

Ashdod, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0002-17-AAA

Identifier Type: -

Identifier Source: org_study_id

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