Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Primary Purpose
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Local anesthesia with lidocaine and adrenalin.
lidocaine and adrenalin
lidocaine and arterial blockage
Sponsored by
About this trial
This is an interventional diagnostic trial for Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Eligibility Criteria
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
Sites / Locations
- Assuta Ashdod Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Local anesthesia of lidocaine and arterial blockage on the arm
Local anesthesia with lidocaine and adrenalin
Arm Description
Local anesthesia of lidocaine and arterial blockage on the arm
Local anesthesia with lidocaine and adrenalin
Outcomes
Primary Outcome Measures
Arrhythmia
Arrhythmia
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04029610
Brief Title
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Official Title
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Uri farkash
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local anesthesia of lidocaine and arterial blockage on the arm
Arm Type
Active Comparator
Arm Description
Local anesthesia of lidocaine and arterial blockage on the arm
Arm Title
Local anesthesia with lidocaine and adrenalin
Arm Type
Experimental
Arm Description
Local anesthesia with lidocaine and adrenalin
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia with lidocaine and adrenalin.
Intervention Description
Local anesthesia with lidocaine and adrenalin.
Intervention Type
Drug
Intervention Name(s)
lidocaine and adrenalin
Intervention Description
lidocaine and adrenalin
Intervention Type
Drug
Intervention Name(s)
lidocaine and arterial blockage
Intervention Description
lidocaine and arterial blockage
Primary Outcome Measure Information:
Title
Arrhythmia
Description
Arrhythmia
Time Frame
1 day of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Farkash, MD
Organizational Affiliation
Head, Hand Surgery Unit, Assuta Ashdod Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta Ashdod Hospital
City
Ashdod
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
We'll reach out to this number within 24 hrs