Protocol summary

Study aim
Determining the average score of edema and ecchymosis after rhinoplasty with local anesthetic injection of triamcinolone lidocaine adrenaline solution compared to lidocaine adrenaline solution: a randomized clinical trial
Design
A clinical trial without a control group, with parallel groups, double-blind, randomized, phase 2 for 70 patients, was used to randomize the table of random numbers generated by the computer.
Settings and conduct
The location of the Study is the operating room of Al-Zahra Hospital, Zahedan. The procedure is that the operating room technician prepares a 10 cc syringe 15 minutes before the operation and the injection is performed locally in the nasal operation area.
Participants/Inclusion and exclusion criteria
Entry criteria: men and women aged 18 to 35 who visit Al-Zahra Zahedan Hospital for rhinoplasty. Exclusion criteria: patients with a history of gastric ulcer, diabetes mellitus, body deformity disorder, tuberculosis, herpes simplex, high blood pressure, known allergy to triamcinolone, lidocaine or adrenaline, preoperative use of anticoagulant treatment 5 days before the operation, disorders Blood and fibrinolytic will be excluded from the study.
Intervention groups
Group A: 10 cc of 2% lidocaine combined with 1% adrenaline will receive. Group B: 10 cc of lidocaine combined with one hundred thousand and ten mg of adrenaline will receive triamcinolone acetate ampoules. The solutions are prepared by the operating room expert 15 minutes before the operation in a 10 cc syringe and will be injected locally in the nose operation area.
Main outcome variables
Digital photos will be taken on the first, third and seventh days after the operation. An expert examiner at the institution, blinded to the study, will evaluate patient photographs and score eyelid edema and ecchymosis according to the scale described by Gurlek et al.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231030059908N5
Registration date: 2024-10-03, 1403/07/12
Registration timing: registered_while_recruiting

Last update: 2024-10-03, 1403/07/12
Update count: 0
Registration date
2024-10-03, 1403/07/12
Registrant information
Name
Fateme Mollazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 4944
Email address
f.mollazade1159@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-15, 1403/06/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of mean score of edema and ecchymosis after rhinoplasty by injection of local anesthetic with triamcinolone lidocaine adrenaline solution in comparison with lidocaine adrenaline solution.
Public title
Investigating the average score of edema and ecchymosis after rhinoplasty with local anesthetic injection of triamcinolone lidocaine adrenaline solution compared to lidocaine adrenaline solution
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women aged 18 to 35 who visit Al-Zahra Zahedan Hospital for rhinoplasty
Exclusion criteria:
Patients with a history of gastric ulcer. History of Diabetes mellitus Body deformity disorder History of Tuberculosis History of Herpes simplex History of Hypertion Known allergy to Triamcinolone Known allergy to Lidocaine Known allergy to Adrenaline Use of anticoagulant treatment 5 days before the operation Blood and fibrinolytic disorders
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, based on the individual, the statistical software's randomization tool, is how to create a random sequence based on a table of random numbers. Every person who comes to the hospital for rhinoplasty and wants to participate in the study will be randomly entered into one of the groups by computer.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study are unaware of the type of medicine they are receiving. Operating room technicians who inject drugs are unaware of the type of drug in each syringe The trusted doctor who examines the patients two days after the operation in terms of edema and ecchymosis is unaware of the type of medicine used for each patient.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of University of Medical Sciences, Zahedan
Street address
Dr. Hasabi Square, Medical Sciences Campus, Zahedan Town.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.ZAUMS.REC.1401.153

Health conditions studied

1

Description of health condition studied
Ecchymosis after rhinoplasty
ICD-10 code
S05.2
ICD-10 code description
Ocular laceration and rupture with prolapse or loss of intraocular tissue

2

Description of health condition studied
Edema after rhinoplasty
ICD-10 code
R60.0
ICD-10 code description
Localized edema

Primary outcomes

1

Description
Based on the observation of a specialist doctor and the grading form of periorbital edema.
Timepoint
3, 5, 7 days after the start of the operation.
Method of measurement
The scale described by Gurlek et al.

2

Description
Edma
Timepoint
3, 5, 7 days after the start of the operation.
Method of measurement
The scale described by Gurlek et al.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention First group: Group A: 10 cc of 2% lidocaine combined with 1% adrenaline will receive
Category
Treatment - Drugs

2

Description
Intervention group: Group B will receive 10 cc of lidocaine combined with one hundred thousand and ten milligrams of triamcinolone acetate.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Zahedan Hospital
Full name of responsible person
Gholamali Dashti Khovidaki
Street address
Shaheed Motahari Blvd, Al-Zahra Hospital, Zahedan Town.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
Alzahra_eyecenter@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ebrahim Kord
Street address
Shahid Motahari Boulevard, Al-Zahra Hospital, Zahedan Town.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
e.kord58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Gholamali Dashti Khovidaki
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Hossein Blvd, Pine Blvd, Zahedan University of Medical Sciences, Zahedan Town..
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
drdashti50@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholamali Dashti Khovidaki
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zahedan, Imam Hossein Blvd, Pine Blvd, Zahedan University of Medical Sciences, Zahedan Town.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00895433295715
Email
drdashti50@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nafisa Ghasemi Mil Kariz
Position
physician
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Farmarez 48.1, No. 31, Mashhad Town.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9197817553
Phone
+98 51 3604 7070
Email
drdashti50@yahoo.com

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
No - There is not a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
To publish these data, we need more time to make a decision.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in universities and scientific centers
Under which criteria data/document could be used
Any other action should be discussed with the project manager.
From where data/document is obtainable
To the project manager's address: drdashti50@yahoo.com
What processes are involved for a request to access data/document
After sending the request to the mentioned address, their request will be answered as soon as possible.
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