Determining the amount of bleeding during rhinoplasty surgery after not injecting lidocaine
Design
Two arm ;parallel group; randomised trial;phase 1; 42 patients; table of random numbers is used for randomization.
Settings and conduct
1- The place of study: plastic surgery department of Imam Khomeini Hospital and Amir Alam Hospital in Tehran
2- The study population: All referring patients at the age range of 18 and 30 years for open rhinoplasty
3- Blinding: there won't be blinding in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients referred for open rhinoplasty surgery; Patients between the ages of 18 and 30.
Non-Inclusion criteria:
coagulation and platelet disorder; broken nose; allergy to lidocaine; high blood pressure; smoking.
Intervention groups
Intervention group: In this group, only 1/100000 epinephrine solution with a volume of 10 cc is injected in the nasal surgery field.
Control group: In this group, 100000/1 epinephrine solution along with 1% lidocaine with a volume of 10 cc is injected in the nasal surgery field.
Main outcome variables
The amount of bleeding during rhinoplasty surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230508058122N1
Registration date:2023-07-01, 1402/04/10
Registration timing:registered_while_recruiting
Last update:2023-07-01, 1402/04/10
Update count:0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Hesamodin Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 3414
Email address
hesam154982p@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-24, 1402/04/03
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of not injecting lidocaine on the bleeding rate during open rhinoplasty
Public title
The effect of not injecting lidocaine on the bleeding rate of open rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred for open rhinoplasty surgery
Age range of 18 to 30 years
Exclusion criteria:
Coagulopathy
Nasal bone fracture
Hypersensitivity reaction to lidocaine
Smoking
Hypertension
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the table of random numbers and considering that the sample size in this study is 42 patients, each patient is given a 2-digit code. (01, 02, 03, 04 and...)
To select sample people from the table, randomly start from a point of the table in the direction of the row or column of two-digit numbers, and the selection of the point is done by closing the eyes and placing a finger or the tip of the pen on the table. Movement does not differ in row or column direction
The selected number is actually the code of an individual from the community that is selected as a sample. This work continues until the number of sample people can be selected. After the sample volume is complete, the sampling work ends.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Baqerkhan Street, Imam Khomeini Hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.103
Health conditions studied
1
Description of health condition studied
Open rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the amount of bleeding during rhinoplasty
Timepoint
At the end of surgery
Method of measurement
Bleeding volume in cc
Secondary outcomes
1
Description
Eye ecchymosis
Timepoint
The first day after surgery
Method of measurement
Gurlec criterion
2
Description
The quality of the surgical field
Timepoint
During surgery
Method of measurement
Boezaart criterion
3
Description
Surgeon satisfaction
Timepoint
During surgery
Method of measurement
Likert criterion
Intervention groups
1
Description
Intervention group: In this group, epinephrine solution with a concentration of 1.100000with a volume of 10 cc is injected in the nasal surgical field at the beginning of the surgery.
Category
Treatment - Drugs
2
Description
Control group: In this group, epinephrine solution with a concentration of 1.100000 along with lidocaine with a concentration of 1% with a volume of 10 cc is injected at the beginning of the surgery in the nasal surgery field
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Hesamodin Karimi
Street address
Baqerkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Amiralam hospital
Full name of responsible person
Hesamodin Karimi
Street address
Saadi street
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6634 3352
Email
hamiralam@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotuhi
Street address
baqerkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119
Email
Imamhospital@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hesamodin Karimi
Position
Assistant of plastic surgery subspecialty course
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imamkhomeini hospital; Baqerkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 2283 3414
Email
hesam154982p@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hesamodin Karimi
Position
Assistant of plastic surgery subspecialty course
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imamkhomeini hospital; Baqerkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 2283 3414
Email
hesam154982p@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hesamodin Karimi
Position
Assistant of plastic surgery subspecialty course
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imamkhomeini hospital; Baqerkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 2283 3414
Email
hesam154982p@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD