Comparison of Ofsar ointment and EMLA (procaine+lidocaine) ointment in local analgesia for access to vein in cardiac surgery patients before induction of anesthesia
In open heart surgery for coronary artery bypass grafting, it requires the patient have not been any stress and pain until surgery. Venipuncture procedure is one of the processes that can cause pain before the surgery for patients. In order to prevent this pain, is applied local anesthetics especially combination of Prilocaine and lidocaine in EMLA cream format. Wormwood (apsinthion) has also been shown to have similar effects with this ointment that is comparison in this study (Phase I) between EMLA classical ointments with composition wormwood (apsinthion). In animal studies it has been done successfully and without complications. The study included 40 patients which are divided into two groups. For each patient have one gray angiocatheter with EMLA on hand and another gray angiocath with wormwood (apsinthion) on the other patient hand, the pain and hemodynamic changes and complications are compared. The study was double-blind and randomized. Inclusion criteria: All patients undergoing open heart surgery, coronary artery in Ekbatan center in Hamadan, elective surgery, patients between 18 to 75 years. Exclusion criteria: patient dissatisfaction, perform venipuncture on unconventional path, sensory and neurological disorders in the upper limbs
General information
Acronym
ofsar ointment
IRCT registration information
IRCT registration number:IRCT2013120715696N1
Registration date:2014-01-10, 1392/10/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-10, 1392/10/20
Registrant information
Name
Afshin Farhanchi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 1244
Email address
farhanchi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Hamedan University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ofsar ointment and EMLA (procaine+lidocaine) ointment in local analgesia for access to vein in cardiac surgery patients before induction of anesthesia
Public title
Assessment efficacy and complications of OFSAR Wormwood (apsinthion)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : all patients undergoing open heart surgery, coronary artery in Ekbatan center in Hamadan; elective surgery; patients aged between 18 to 75 years old. Exclusion criteria: patient dissatisfaction; perform venipuncture on unconventional path; sensory and neurological disorders in the upper limbs.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Control group and intervention group are the same. One of the upper limbs are for control group and the other for intervention group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Scienses
Street address
Hamedan University of Medical Scienses, Mahdie street
City
Hamedan
Postal code
65178
Approval date
2013-05-01, 1392/02/11
Ethics committee reference number
275/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
CABG: coronery arthery bypass grapht
ICD-10 code
121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Painless effect
Timepoint
40 minute befor Producer
Method of measurement
VAS index
Secondary outcomes
1
Description
Complication
Timepoint
24 hours after producer
Method of measurement
Check list
Intervention groups
1
Description
Intervention group on one hand with ofsar ointment
Category
Treatment - Drugs
2
Description
control group on other hand with EMLA ointment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan hospital
Full name of responsible person
Afshin Farhanchi
Street address
Taleghani street
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bashirian
Street address
Hamedan University of Medical Sciences, Mahdieh street
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Farhanchi
Position
Assisted professor in anesthesia and critical care
Other areas of specialty/work
Street address
Ekbatan hospital, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1825 1244
Fax
+98 81 1835 1660
Email
afarhanchi1970@yahoo.com; farhanchi@umsha.ac.ir;
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afashin Farhanchi
Position
MD / Assisted professor in anesthesia and critical care