Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With AdrenalineNCT04029610
Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
A study testing Local anesthesia with lidocaine and adrenalin., lidocaine and adrenalin and lidocaine and arterial blockage in people with Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline, run by Uri farkash at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
- What is being tested?
- Local anesthesia with lidocaine and adrenalin., lidocaine and adrenalin and lidocaine and arterial blockage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Aug 2018to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients who undergo hand surgery using local anesthesia at Assuta Ashdod Hospital
Who cannot join
- Patients with a known medical history of cardiac arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Local anesthesia with lidocaine and adrenalin., lidocaine and adrenalin, lidocaine and arterial blockage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia with lidocaine and adrenalin.Procedure or surgery
Local anesthesia with lidocaine and adrenalin.
lidocaine and adrenalinDrug
lidocaine and adrenalin
lidocaine and arterial blockageDrug
lidocaine and arterial blockage
| Study group | Role | What they receive |
|---|---|---|
| Local anesthesia of lidocaine and arterial blockage on the arm | Active comparator | Local anesthesia of lidocaine and arterial blockage on the arm Receives: Drug: lidocaine and arterial blockage |
| Local anesthesia with lidocaine and adrenalin | Experimental | Local anesthesia with lidocaine and adrenalin Receives: Procedure: Local anesthesia with lidocaine and adrenalin.; Drug: lidocaine and adrenalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia
Arrhythmia
Measured: 1 day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start14 Aug 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With AdrenalineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uri farkash
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uri farkash, Assuta Ashdod Hospital
- Investigators
- Uri Farkash, MD, Principal investigator, Head, Hand Surgery Unit, Assuta Ashdod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029610
- Sponsor's protocol ID
- 0002-17-AAA
- Status last verified
- Mar 2022
- First submitted
- 20 Jul 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline
- ClinicalTrials.gov ID
- NCT04029610
- Acronym / sponsor ID
- 0002-17-AAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Uri farkashUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia of lidocaine and arterial blockage on the arm | Active comparator | Drug: lidocaine and arterial blockageLocal anesthesia of lidocaine and arterial blockage on the arm |
| Local anesthesia with lidocaine and adrenalin | Experimental | Procedure: Local anesthesia with lidocaine and adrenalin., Drug: lidocaine and adrenalinLocal anesthesia with lidocaine and adrenalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who undergo hand surgery using local anesthesia at Assuta Ashdod Hospital
Key exclusion criteria (1 listed)
- Patients with a known medical history of cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthesia with lidocaine and adrenalin.Local anesthesia with lidocaine and adrenalin. | Procedure or surgery | Local anesthesia with lidocaine and adrenalin |
| lidocaine and adrenalinlidocaine and adrenalin | Drug | Local anesthesia with lidocaine and adrenalin |
| lidocaine and arterial blockagelidocaine and arterial blockage | Drug | Local anesthesia of lidocaine and arterial blockage on the arm |
Primary outcome
Arrhythmia
Time frame: 1 day of procedure
Arrhythmia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri Farkash, MD principal investigator
Head, Hand Surgery Unit, Assuta Ashdod Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthesia with lidocaine and adrenalin., lidocaine and adrenalin and lidocaine and arterial blockage in people with Evaluation of Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia With Adrenaline, run by Uri farkash at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia (time frame: 1 day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.