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Clinical Trials/NCT04029610
NCT04029610CompletedNot Applicable

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

Uri farkash1 site in 1 country110 target enrollmentStarted: August 14, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
Arrhythmia

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Local anesthesia of lidocaine and arterial blockage on the arm

Active Comparator

Local anesthesia of lidocaine and arterial blockage on the arm

Intervention: lidocaine and arterial blockage (Drug)

Local anesthesia with lidocaine and adrenalin

Experimental

Local anesthesia with lidocaine and adrenalin

Intervention: Local anesthesia with lidocaine and adrenalin. (Procedure)

Local anesthesia with lidocaine and adrenalin

Experimental

Local anesthesia with lidocaine and adrenalin

Intervention: lidocaine and adrenalin (Drug)

Outcomes

Primary Outcomes

Arrhythmia

Time Frame: 1 day of procedure

Arrhythmia

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Uri farkash
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Uri farkash

Head, Hand Surgery Unit, Assuta Ashdod University Hospital

Assuta Ashdod Hospital

Study Sites (1)

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