In head and neck surgeries, bleeding in surgical field has an important role in decrease of operation time and also it prevents blood transfusion complications. An effective method for decrease blood in surgical field is infiltration of adrenaline. Adrenaline usually diluted with lidocaine, but lidocain has a vasodilator effect. The study compare amount of blood in surgical field between lidocain group and control group (without lidocain). The study is done in patients with ASA class I and II candidate for rhinoplastic surgery; they are divided to two groups (lidocain and control) randomly. In lidocain group adrenaline and 2% lidocain is used and in control group adrenaline and saline. Then the amount of bleeding in surgical field is documented and then compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502172946N6
Registration date:2015-03-08, 1393/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-08, 1393/12/17
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisonal survey of local infiltration of adrenalized lidocain with adrenaline alone in operative field bleeding in Rhinoplastic surgery
Public title
study of effect of lidocain infiltration in surgical field bleeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 15-45 years old; ASA class I and II.
Exclusion criteria: coagulopathy; heart diseases; hypertension.
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
No. 2 building of Medical University, Shahid Beheshti boulevard
City
Kermanshah
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
53879
Health conditions studied
1
Description of health condition studied
Amount of bleeding in surgical field
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck
Primary outcomes
1
Description
The amount of surgical bleeding
Timepoint
Every 10 minute during surgery
Method of measurement
Blood in suction and gauze
Secondary outcomes
1
Description
Surgical field bleeding
Timepoint
Every 10 minute
Method of measurement
Boezaart quality scale of bleeding
Intervention groups
1
Description
In intervention group( lidocain group )adrenaline 1/200000 and 2% lidocain is infiltrated intradermal in surgical field and every 10 minute scale of surgical field bleeding was documented and at the end of operation total amount of bleeding was documented
Category
Prevention
2
Description
In control group adrenaline 1/200000 and saline 0.9% is infiltrated intradermal in surgical field and every 10 minute scale of surgical field bleeding was documented and at the end of operation total amount of bleeding was documented
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mitra Yari
Street address
Parastar boulevard, Sorkhalijeh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
No. 2 building of Medical University, Shahid Beheshti boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?