Aim: Comparison effect between topical ARNICA pomade and Bupivacaine injection in pain relief at surgical incision for patient with Varicocele operation in Hamadan Shahid Beheshti Hospital. Design: double blind randomized clinical trial. Setting: Patients with Varicocele surgery them refer to Shahid Beheshti Hospital in Hamadan in 2017-2018. Inclusion criteria: (a)patients with class 1 or 2 according to the American Society of Anesthesiology scoring criteria; (b)age of 20-60 years;(c)no history of Psychotropic or Opium drugs consumption; (d)Lack of long-term use of nonsteroidal anti inflammatory drugs; (e)Lack of systemic disease; (f)Lack of sensitivity to medications used.
Exclusion criteria: (a)Lack of any of the inclusion criteria; (b)Lack of patient cooperation.
Patients were randomly placed into three groups every group have 42 member and using general anesthesia and same Protocols and primary outcome is pain severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702149597N2
Registration date:2017-03-13, 1395/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Seyed Mohamad Zolhavarieh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
sm.zolhavarieh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-02-28, 1395/12/10
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect between topical ARNICA pomade and Bupivacaine injection in pain relief at surgical incision for patient with Varicocele operation
Public title
Comparing effect between topical ARNICA pomade and Bupivacaine injection in pain relief at surgical incision for patient with Varicocele operation in Hamedan Shahid Beheshti Hospital on 2017-2018
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a)patients with class 1 or 2 according to the American Society of Anesthesiology scoring criteria; (b)age of 20-60 years;(c)no history of Psychotropic or Opium drugs consumption; (d)Lack of long-term use of nonsteroidal anti inflammatory drugs; (e)Lack of systemic disease; (f)Lack of sensitivity to medications used.
Exclusion criteria: (a)Lack of any of the inclusion criteria; (b)Lack of patient cooperation.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
ice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.502
Health conditions studied
1
Description of health condition studied
Pain localized to other parts of lower abdomen
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
Pain severity
Timepoint
1, 6, 12, , and 24 hours after surgery
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
side effects of of drugs
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
questionnaire
2
Description
Opium dose (mg) usage
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
questionnaire
3
Description
Hemodynamic status
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
1hours before surgery, 5g of topical Arnica pomade use.
Category
Treatment - Other
2
Description
Injection (10 ml) bupivacaine 0.25% at the end of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Seyed Mohammad Zolhavarieh
Street address
Shahid Beheshti Hospital, Eram Blv.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Habib Mosavi-Bahar
Position
Professor
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517953371
Phone
+98 118380273
Fax
Email
shmbahar@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Board of Anesthesiology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital Eram Blv.
City
Hamadan
Postal code
6517953371
Phone
+98 138380749
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Board of Anesthesiology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital Eram Blv.
City
Hamadan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)