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

Not Applicable

Completed

• Conditions: Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
• Interventions: Drug: lidocaine and arterial blockage; Procedure: Local anesthesia with lidocaine and adrenalin.; Drug: lidocaine and adrenalin

• Registration Number: NCT04029610
• Lead Sponsor: Uri farkash

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 Timeline

• Study Start: 2018-08-14
• Study First Submitted: 2019-07-20
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-23
• Primary Completion: 2019-12-01
• Study Completion: 2020-12-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local anesthesia with lidocaine and adrenalin	lidocaine and adrenalin	Local anesthesia with lidocaine and adrenalin
Local anesthesia of lidocaine and arterial blockage on the arm	lidocaine and arterial blockage	Local anesthesia of lidocaine and arterial blockage on the arm
Local anesthesia with lidocaine and adrenalin	Local anesthesia with lidocaine and adrenalin.	Local anesthesia with lidocaine and adrenalin

Primary Outcome Measures

Name	Time	Method
Arrhythmia	1 day of procedure	Arrhythmia

Trial Locations

Locations (1)

Assuta Ashdod Hospital; 🇮🇱 Ashdod, Israel