Comparative evaluation of cardiovascular effects of 0.5% Ropivacaine front 2% Lidocaine with 1:80000 epinephrine in implant surgery, A double-blind crossover clinical trial
Choosing the appropriate anesthetic drug with the least adverse systemic effects.
Design
This study is a double-blind, crossover randomized clinical trial, in phase 2 as a clinical trial, which performs on 18 patients.In each patient, on one side 2% lidocaine with epinephrine 1/800000 and on the other side 0.5% ropevacaine will be injected. Simple randomization by dropping the coin will be performed to determine the type of anesthetic drug, as well as the surgical site in the first session.
Settings and conduct
This study will be performed in the periodontics department of Shahid Beheshti Dental School. 3.6 ml of each anesthetic drug will be injected in each area with the same technique, in the mandible as buccal and lingual infiltration, and in the maxilla as buccal infiltration and greater palatine block. Patient and surgeon are unaware of the type of drug.
Participants/Inclusion and exclusion criteria
Systemically healthy individuals who need to recieve one implant bilaterally in the molars or premolars area in one jaw are selected. Areas in which bone augmentation, sinus lift surgery and immediate implant placement is needed are excluded.
Intervention groups
Patients who need to recieve 1 implant in the posterior areas in one jaw (left and right) are included in the study. On one side, 0.5% ropevacaine is injected and on the other side, with a 2 weeks interval, 2% lidocaine with 1/800000 epinephrine is injected.
Main outcome variables
Heart rate; systolic and diastolic blood pressure; Saturation of Peripheral Oxygen.; the onset of anesthesia; duration of action; pain during injection and during surgery; duration of postoperative analgesia; analgesic consumption after the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211127053190N1
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Negar Daneshvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4485 9563
Email address
dr.negardaneshvar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-13, 1400/09/22
Expected recruitment end date
2022-06-12, 1401/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of cardiovascular effects of 0.5% Ropivacaine front 2% Lidocaine with 1:80000 epinephrine in implant surgery, A double-blind crossover clinical trial
Public title
Comparison of cardiovascular effects of ropevacaine and lidocaine with epinephrine in implant surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need to place 1 implant bilaterally in the posterior areas (premolar or molar) in one jaw
Systemically healthy individuals (ASA I)
Exclusion criteria:
Patients with a history of allergy to local anesthetic agents, amides and sulfides
Patients with acute or chronic infection near the surgical site
Smokers
Alcohol consumption
Consumers of antipsychotic drugs, antidepressants and oral contraceptives
People who have taken painkillers in the 48 hours before surgery
People with a history of chronic facial pain
Pregnant and lactating women
Patients who need immediate implant placement (class1)
Patients who need open / closed sinus lift surgery at the surgical site
Patients who need bone augmentation (GBR) at the surgical site
Patients who refuse to take part in the research
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
18
More than 1 sample in each individual
Number of samples in each individual:
2
The surgical procedure involves injecting lidocaine on one side of the jaw and ropivacaine on the other side
Randomization (investigator's opinion)
Randomized
Randomization description
After the patient's eligibility is determined, the procedure will be explained to the patient and moral satisfaction will be obtained. A simple randomization method is used. The surgical site as well as the type of local anesthesia in the first session are both determined by dropping the coin by the assistant. Both sides (left and right) in a jaw will recieve 1 implant with the same surgical procedure without bone augmentation. Two weeks later, surgery will be performed on the other side with the other anesthetic drug.
Blinding (investigator's opinion)
Double blinded
Blinding description
After determining the type of anesthesia for the first session by dropping the coin, the assistant draws up the drug into the insulin syringes, and delivers it to the surgeon. The assistant will be the only aware person of the type of drug and has no role in further procedures. Both anesthetic drugs are colorlessness and clear, so the insulin syringes will not be covered. After completing the injection and starting the surgery, the parameters are recorded by the surgeon. Both the patient and the surgeon are unaware of the type of local anesthesia.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti School of Dentistry, Daneshjou Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SBMU.DRC.REC.1399.018
Health conditions studied
1
Description of health condition studied
Hemodynamic effects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection
Method of measurement
Pulse Oximeter
2
Description
Systolic blood pressure
Timepoint
Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection
Method of measurement
Wrist Blood Pressure Monitor
3
Description
Diastolic blood pressure
Timepoint
Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection
Method of measurement
Wrist Blood Pressure Monitor
4
Description
Saturation of Peripheral Oxygen (SPo2)
Timepoint
Before the injection, immediately after the injection, 10 minutes after the injection, 20 minutes after the injection, 30 minutes after the injection, 1 hour after the injection
Method of measurement
Pulse Oximeter
5
Description
Onset of anesthesia
Timepoint
From the time when the needle is pulled out of the tissue
Method of measurement
Stopwatch
6
Description
Duration of anesthesia
Timepoint
From the time when the needle is pulled out of the tissue until the anesthetic effect wears off
Method of measurement
Stopwatch
7
Description
The amount of pain felt during the injection
Timepoint
During the injection
Method of measurement
Visual Analogue Scale
8
Description
The amount of pain felt during the surgery
Timepoint
During the surgery
Method of measurement
Visual Analogue Scale
9
Description
Duration of analgesia after the surgery
Timepoint
From the time when the needle is pulled out of the tissue until the time of the onset of pain after the surgery
Method of measurement
Stopwatch
10
Description
Numbers of painkillers taken after the surgery
Timepoint
After the end of the surgery to 1 week
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 10 millilitre vial of 0.5% ropivacaine made by Molteni Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins.
Category
Prevention
2
Description
Control group: 3.6 millilitre of the anaesthetic solution is drawn with insulin syringes from 1.8 millilitre carpules of 2% lidocaine with epinephrine 1/80000 made by Darou Pakhsh Pharmaceutical Company. The injection technique in lower jaw is buccal and lingual infiltration (1 millilitre and 1 millilitre), and in upper jaw is buccal infiltration and greater palatine block (1.5 millilitre and 0.5 millilitre). Then performing the surgical steps of placing a dental implant begins.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti dental school
Full name of responsible person
Negar Daneshvar
Street address
Shahid beheshti dental school, Daneshjou Blvd, Evin, Tehran
City
Teharn
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3010
Email
dr.negardaneshvar@sbmu.ac.ir
Web page address
https://dentistry.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid beheshti university of medical science, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negar Daneshvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid beheshti dental school, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3010
Email
dr.negardaneshvar@sbmu.ac.ir
Web page address
https://dentistry.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negar Daneshvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid beheshti dental school, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3010
Email
dr.negardaneshvar@sbmu.ac.ir
Web page address
https://dentistry.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negar Daneshvar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid beheshti dental school, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2240 3010
Email
dr.negardaneshvar@sbmu.ac.ir
Web page address
https://dentistry.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available