Investigation of the effect of local anesthesia with epinephrine (with Inferior Alveolar Nerve Block anesthesia technique) on blood pressure of people applying for tooth extraction
Determining the effect of local anesthesia with epinephrine on blood pressure of candidates for tooth extraction using the Inferior Alveolar Nerve Block anesthesia technique
Design
Two arm parallel group double blinded randomised trial phase 3 on 40 participants that STATA software is used for randomization.
Settings and conduct
In order to obtain complete anesthesia, two Lidocaine carpoles or two Citanest carpoles will be infusioned. In order to reduce the operating error, all injections will be performed by one person. The type of injection in these people will be alveolar inferior nerve block after negative aspiration. Systolic and diastolic blood pressure and heart rate in each patient are measured in four stages by another person who is unaware of the type of anesthesia.
1. After the patient sits in a chair for 5 minutes.
2. After the injection, the patient was completely anesthetized.
3. At the end of the operation after the tooth is removed.
4. Finally in 5 minutes after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria in this study 1. All patients referred to the surgical department of Bandar Abbas Dental School 2. Patients have no systemic problems and have general health.
Exclusion criteria in this study 1. Patients who are reluctant to cooperate, 2. Patients with cardiovascular problems, 3. Patients with uncontrolled blood pressure, and 4. Patients with uncontrolled hyperthyroidism.
Intervention groups
First intervention group: In this group, local anesthesia of Inferior Alveolar Nerve Block will be used using lidocaine along with epinephrine.
Second intervention group (Control): In this group, local anesthesia of Inferior Alveolar Nerve Block will be used using Citanest drug (lidocaine without epinephrine).
Main outcome variables
Systolic blood pressure
Diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200705048014N1
Registration date:2020-08-21, 1399/05/31
Registration timing:registered_while_recruiting
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Mohammad Reza Moaddeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3335 0458
Email address
m.moaddeli@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of local anesthesia with epinephrine (with Inferior Alveolar Nerve Block anesthesia technique) on blood pressure of people applying for tooth extraction
Public title
Investigation of the effect of local anesthesia with epinephrine on blood pressure of people applying for tooth extraction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have referred for tooth extraction and use Inferior Alveolar Nerve Block anesthesia for anesthesia
Patients who have no systemic problems and are in good general health.
Exclusion criteria:
Patients who do not want to cooperate.
Patients with cardiovascular problems.
Patients with uncontrolled blood pressure.
Patients with uncontrolled hyperthyroidism.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Stochasticization process In this study, quadruple blocks are randomly divided into two groups. One group receiving anesthesia containing epinephrine and one group receiving anesthesia without epinephrine.
Randomization is done in individual units using STATA software and Block Randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not informed of the medication to be taken and the anesthetic carpole is placed in the injection syringe before the patient is present and the evaluator is not aware of the type of anesthetic injection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Ethics Committee of Bandar Abbas University of Medical Sciences,Research Deputy Building, Shahid Mohammadi Hospital, Jomhoori Islami Blvd.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.HUMS.REC.1398.389
Health conditions studied
1
Description of health condition studied
Blood-pressure
ICD-10 code
R03.0
ICD-10 code description
Elevated blood-pressure reading, without diagnosis of hypertension
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Systolic blood pressure is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth is removed. 4- Five minutes after the tooth is removed.
Method of measurement
Systolic blood pressure is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using a calibrated EmSig sphygmomanometer.
2
Description
Diastolic blood pressure
Timepoint
Diastolic blood pressure is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth is removed. 4- Five minutes after the tooth is removed.
Method of measurement
Diastolic blood pressure is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using a calibrated EmSig sphygmomanometer.
3
Description
Heart rate
Timepoint
Heart rate is measured in four stages. 1- Five minutes before the anesthetic injection. 2- Immediately after anesthesia injection. 3- Immediately after the tooth is removed. 4- Five minutes after the tooth is removed.
Method of measurement
Heart rate is measured in each patient at all four stages by a dentist who does not know the type of anesthesia using an EmSig stethoscope.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group were injected with two carpools of lidocaine containing 108 mg of lidocaine and 0.054 mg of epinephrine for local anesthesia.
Category
Other
2
Description
Control group: Patients in this group are injected with two carpooles of Citanest containing 162 mg of Citanest for local anesthesia.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Bandar Abbas Faculty of Dentistry
Full name of responsible person
Mohammad Reza Moaddeli
Street address
Dental Clinic of Bandar Abbas School of Dentistry, Shahid Naser St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7914964153
Phone
+98 76 3335 0458
Email
hums@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teamour Aghamolai
Street address
Shahid Mohammadi Hospital, Jomhouri Islami St, Imam Khomeini Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Email
taghamolaei@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Reza Moaddeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Imam Khomeini Blvd.
City
Badar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3335 0458
Fax
Email
m.moaddeli@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Mohammad Reza Moaddeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Imam Khomeini Blvd.
City
Badar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3335 0458
Fax
Email
m.moaddeli@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hadis Ansari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Imam Khomeini Blvd.
City
Badar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3335 0458
Fax
Email
vania-f@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information from this study can be shared without identifying participants.
When the data will become available and for how long
2021/3/21
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources and references
From where data/document is obtainable
Dr. Mohammad Reza Moaddeli
m.moaddeli@hums.ac.ir
What processes are involved for a request to access data/document
The request must first be emailed and answered after review and approval.