The effect of infiltration of pterygopalatine fossa with lidocaine and epinephrine solution on intraoperative bleeding during endoscopic sinonasal surgeries in chronic sinusitis patients attending Amir-Almomenin hospital in Rasht
The effect of infiltration of pterygopalatine fossa with lidocaine and epinephrine solution on intraoperative bleeding during endoscopic sinonasal surgeries in chronic sinusitis patients
Design
Double blind randomized clinical trial by block randomization via sealed envelope software for outcome assessment
Settings and conduct
Chronic rhinosinusitis patients attending Amir-almomenin hospital during 2021candidate for endoscopic sinus surgery will be assessed for bleeding during surgery after infiltration of pterygopalatine fossa. Patients, surgeon and questionnaire filler are blind for the solution contents.
Participants/Inclusion and exclusion criteria
Chronic rhinosinusitis patients with and without polyposis, who are 18-65 years old and are candidate for endoscopic sinus surgery after maximal medical therapy are included
Intervention groups
Study group would be the side infiltrated by lidocaine and epinephrin solution in pterygopalatine fossa, in control side normal saline would be injected.
Main outcome variables
Blood volume during surgery
Surgical field grading using Boezaart scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210307050609N1
Registration date:2021-05-09, 1400/02/19
Registration timing:registered_while_recruiting
Last update:2021-05-09, 1400/02/19
Update count:0
Registration date
2021-05-09, 1400/02/19
Registrant information
Name
Sevil Nasirmohtaram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 8307
Email address
sevil198@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of infiltration of pterygopalatine fossa with lidocaine and epinephrine solution on intraoperative bleeding during endoscopic sinonasal surgeries in chronic sinusitis patients attending Amir-Almomenin hospital in Rasht
Public title
The effect of infiltration of pterygopalatine fossa with lidocaine and epinephrine solution on intraoperative bleeding during endoscopic sinonasal surgeries in chronic sinusitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic sinusitis with or without polyposis with symmetric disease on both sides,candidate for endoscopic sinus surgery after maximal medical treatment, are included.
Exclusion criteria:
History of coagulopathies, strict indication to use anti-coagulant drug,history of dysrhythmia or cardiac disease,history of lidocaine sensitivity, patients candidate for unilateral surgery, history of garlic, ginseng,vitamin E or fish oil consumption in recent 2weeks
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients would be randomly classified as intervention and control group with block randomization in 10 blocks of 4 by allocating a specific code number using Sealed Envelope software.
Blinding (investigator's opinion)
Double blinded
Blinding description
patient is unaware of placebo or drug side
surgeon, clinician who fulfills the operative checklist, and data analyzer are all blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gilan University of Medical Sciences
Street address
NO. 17,108 Ave., Golsar Blvd., Rasht, Gilan
City
Rasht
Province
Guilan
Postal code
4165755199
Approval date
2021-02-17, 1399/11/29
Ethics committee reference number
IR.GUMS.REC.1399.606
Health conditions studied
1
Description of health condition studied
surgical field blood using Beozaart scale
ICD-10 code
ICD-10 code description
2
Description of health condition studied
intraoperative blood volume assessed by estimating blood volume in the bottle and number of cotton bands soaked in blood
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intraoperative bleeding
Timepoint
Every 15 minutes during surgery
Method of measurement
Boezaart scale and blood volume in milliliter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after induction of general anesthesia 2 cc of lidocain plus epinephrin solution in injected into pterygopalatine fossa through greater palatin foramen with an angle of 45 degrees
Category
Treatment - Drugs
2
Description
Control group: :ion group after induction of general anesthesia 2 cc of normal saline solution in injected into pterygopalatine fossa through greater palatin foramen with an angle of 45 degrees
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-almomenin hospital
Full name of responsible person
Sevil Nasirmohtaram
Street address
No.17, 108Ave., Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Street address
No.17,108 Ave., Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.17, 108 Ave., Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No. 17, 108 Ave., Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3211 9653
Email
sevil198@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sevil Nasirmohtaram
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.17, 108Ave., Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4165755199
Phone
+98 13 3322 5242
Email
sevil198@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
after hiding personal data of patients it is possible
When the data will become available and for how long
6 months after publishing data
To whom data/document is available
researchers and scientific and academic organs
Under which criteria data/document could be used
exclusively for scientific reasons
From where data/document is obtainable
corresponding writer
What processes are involved for a request to access data/document
It can be accessed during 1 month from sending a letter through email, after brief explanation about reason of request and scientific position of writer