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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04029610
• Other study ID #: 0002-17-AAA
• Status: Completed
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: March 2022
• Source: Assuta Ashdod Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Local anesthesia with lidocaine and adrenalin.
Local anesthesia with lidocaine and adrenalin.

Drug:
• lidocaine and adrenalin
lidocaine and adrenalin
• lidocaine and arterial blockage
lidocaine and arterial blockage

Locations

Country	Name	City	State
Israel	Assuta Ashdod Hospital	Ashdod

Sponsors (1)

Lead Sponsor	Collaborator
Uri farkash

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia	Arrhythmia	1 day of procedure