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OpenTrials
Completed

NCT Number: NCT04029610

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Ashdod Hospital

Ashdod, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthesia with lidocaine and adrenalin.

Procedure

Local anesthesia with lidocaine and adrenalin.

lidocaine and adrenalin

Drug

lidocaine and adrenalin

lidocaine and arterial blockage

Drug

lidocaine and arterial blockage

Primary outcomes

  1. Arrhythmia

    Time frame: 1 day of procedure

    Arrhythmia

Sponsors and collaborators

Lead sponsor

Uri farkash

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 23, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.