The effect of intraoperative lidocaine-epinephrine administration on complications after tonsillectomy
Design
A randomized double-blind clinical trial with a control group with parallel groups, phase 3 on 110 patients, Permuted block randomization.
Settings and conduct
This study will be performed to evaluate the effect of lidocaine-epinephrine administration in reducing complications after tonsillectomy in patients referred to Kowsar Hospital in Sanandaj.
In this study, in the intervention group, lidocaine impregnated with epinephrine was injected into the tonsil bed during the operation and its effects on reducing complications such as pain and bleeding after the operation were evaluated. In this double-blind study, patients and nurses evaluating the conditions and complications in patients are not aware of grouping.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Informed consent of the patient or parents.
2.Intravenous anesthesia induction planning.
3.Being in Status 1 or 2 ASA classification.
Exclusion Criteria:
1.Sensitivity to local anesthetics.
2.History of cardiovascular disease.
3.Occurrence of life-threatening conditions such as cardiopulmonary arrest.
4.History of mental and psychological disease
Intervention groups
Intervention group:
In this group of patients, lidocaine 1% and epinephrine 1/100,000 are administered in the tonsils bed.
control group:
This group of patients does not have any intervention compared to the usual surgical conditions.
Main outcome variables
1. Pain
2. Bleeding
3. Length of hospitalization.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210314050703N1
Registration date:2021-04-02, 1400/01/13
Registration timing:prospective
Last update:2021-04-02, 1400/01/13
Update count:0
Registration date
2021-04-02, 1400/01/13
Registrant information
Name
Negin Ghadami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 8519
Email address
ghadaminegin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraoperative lidocaine-epinephrine administration on complications after tonsillectomy
Public title
The effect of intraoperative lidocaine-epinephrine administration on complications after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of the patient or parents
Intravenous anesthesia induction planning
Being in Status 1 or 2 ASA classification
Exclusion criteria:
Sensitivity to local anesthetics
History of cardiovascular disease
History of mental and psychological disease
Occurrence of life-threatening conditions such as cardiopulmonary arrest
Age
From 5 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization.
In this method, in each block, 2 patients are randomly identified by assigning codes A or B and based on the assigned code, are placed in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study do not know which control and intervention groups they belong to. Also, the patient evaluating nurse is not aware of the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pardsi of Kurdistan University of Medical Sciences, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.MUK.REC.1398.227
Health conditions studied
1
Description of health condition studied
Hypertrophy of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils
Primary outcomes
1
Description
Pain
Timepoint
30 and 60 minutes after the end of surgery.
Method of measurement
Visual Analogue Scale
2
Description
Bleeding
Timepoint
During surgery and 6, 12 and 24 hours after surgery.
Method of measurement
Based on the number of sterile gases impregnated with blood (each small sterile gas absorbs 4 to 5 ml and each large gas absorbs up to 20 ml).
3
Description
Length of Hospitalization
Timepoint
After patients discharge.
Method of measurement
Based on the day of hospitalization.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of lidocaine 1% - epinephrine 1 in 100,000 in the tonsil bed before surgery. In this group, before starting the surgical procedure, the surgeon injects 4 ml of 1% lidocaine, which is in a syringe soaked in epinephrine 1 in 100,000, into the tonsil bed.
Category
Treatment - Drugs
2
Description
Control group: No intervention is performed and surgery is performed as usual.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital.
Full name of responsible person
Negin Ghadami
Street address
Hamdi St, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3361 1233
Email
KOWSAR@MUK.AC.IR
Web page address
http://muk.ac.ir/Page?pageId=14
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pardis of Kurdistan University of Medical Sciences, Pasadaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4653
Email
ghadaminegin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, faculty of medicine, Kurdistan university of Medical Scineces, Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3361 1233
Email
ghadaminegin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bessat Hospital Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3324 8519
Fax
Email
ghadaminegin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Negin Ghadami
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bessat Hospital Keshavarz street
City
Sanandaj
Province
Kurdistan
Postal code
6616812131
Phone
+98 87 3324 8519
Fax
Email
ghadaminegin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data on the main consequences will be shared.
When the data will become available and for how long
12 Months.
To whom data/document is available
Academic Researchers.
Under which criteria data/document could be used
Meta-Analysis is allowed.
From where data/document is obtainable
Dr. Negin Ghadami
What processes are involved for a request to access data/document