Comparison of the effectiveness of lidocaine and bupivacaine Sub-tenon injection in preventing oculocardiac reflex in strabismus surgery
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 120 patients who will be undergoing strabismus surgery will be enrolled. Eligible patients will be randomly allocated into two equal A and B groups by block randomization.
Settings and conduct
This study will be done in the Operating room and recovery. All of the drugs solution of this study will be prepared by only one person who is aware of the study's grouping, in 4 ml syringes in the same shape. Anesthesiologist, patients, and all medical staff that will collaborate in the study will not aware of the drug allocated to each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adult Patients with ASA class I or II, age between the 18 and 60, who are Candidate for sub-tenon's block.
Exclusion criteria: ASA class of III or IV, Positive history of heart disease, hyperthyroidism and coagulation disorders, Pregnant women and Patient refusal.
Intervention groups
Intervention group A: After induction of anesthesia, 4cc of bupivacaine (brand name Marcaine) will be injected into the sub-tenon space of the operated eye.
Intervention group B: After induction of anesthesia, 4 cc of lidocaine will be injected into the sub-tenon space of the operated eye.
Main outcome variables
Heart rate and Mean arterial pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230122057174N1
Registration date:2023-02-01, 1401/11/12
Registration timing:prospective
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Mehrdad Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
msalari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of lidocaine and bupivacaine Sub-tenon injection in preventing oculocardiac reflex in strabismus surgery
Public title
Comparison of the effects of lidocaine and bupivacaine in preventing oculocardiac reflex in strabismus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA grade I or II (American Society of Anesthesiology classification)
Patients between 18 and 35 years old
Candidate patients for Sub-Tenon's block
Exclusion criteria:
Patients with ASA grade III or IV (American Society of Anesthesiology classification)
Positive history of heart disease
Positive history of hyperthyroidism
Positive history of coagulation disorders
Pregnant women
Patient refusal
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups A & B. In each block, equal numbers for two groups will be considered in alternative positions. Then 20 blocks of size 6 will be selected randomly and
patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.Randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
Identical syringes containing 4 ml of bupivacaine 0.5% or 4 ml of lidocaine 0.5% are provided by the first person, these drugs, which have the same color and size and in similar colors, are injected by the second person who is completely unaware of the contents of the syringes. The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2022-12-18, 1401/09/27
Ethics committee reference number
IR.SUMS.MED.REC.1401.469
Health conditions studied
1
Description of health condition studied
Strabismus
ICD-10 code
H50.9
ICD-10 code description
Unspecified strabismus
Primary outcomes
1
Description
Heart rate
Timepoint
Every 5 minutes during the operation
Method of measurement
Monitoring
2
Description
Mean arterial pressure
Timepoint
Every 5 minutes during the operation
Method of measurement
Monitoring
3
Description
Pain
Timepoint
One hour after the operation
Method of measurement
Questionnaire and Numerical Pain Rating Scale (NRS)
4
Description
Nausea
Timepoint
One hour after the operation
Method of measurement
History taking
5
Description
Vomiting
Timepoint
One hour after the operation
Method of measurement
History taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: After induction of anesthesia, 4cc of bupivacaine (brand name Marcaine) will be injected into the subtenon space of the operated eye.
Category
Treatment - Drugs
2
Description
Intervention group B: After induction of anesthesia, 4 cc of lidocaine will be injected into the subtenon space of the operated eye.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Mohsen Dehghanpoor farashah
Street address
Khalili Street, Shiraz.
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۳۶۹۸۱
Phone
+98 71 3629 1470
Email
khalili@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
7th floor, central building of Shiraz University of Medical Sciences, Vice Chancellor of research, Zand street.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?