The purpose of this study is comparison of efficacy of oral Gabapentin with Tramadol in acute pain control after elective abdominal hysterectomy under general anesthesia. Inclusion criteria: Patients aged 35 to 55; American Society of Anesthesiologists (ASA) class 1-2
Exclusion criteria: The surgical complication leading to prolonged operation time more than 2 hours; Essential requirement to other concomitant abdominal surgery.
This is a double-blind clinical trial study in one hundred twenty patients. Patient are randomly divided in to 3 groups of 40 patients are receiving Tramadol 100 mg and Gabapentin 300 mg and placebo. They are giving medicines 2 hours before surgery with 50 cc water, then Visual analogue scale (VAS) in 4, 8,12,16,20 and 24 hours are investigated and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201108677N1
Registration date:2014-05-13, 1393/02/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-13, 1393/02/23
Registrant information
Name
Farnoush Farzi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
farnoush_farzi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-05-09, 1393/02/19
Expected recruitment end date
2014-09-10, 1393/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of oral Gabapentin and Tramadol after elective abdominal hysterectomy pain in general anesthesia
Public title
Pain control after Hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 35 to 55; American Society of Anesthesiologists (ASA) class 1-2
Exclusion criteria: The surgical complication leading to prolonged operation more than 2 hours; Essential requirement to other abdominal surgery
Age
From 35 years old to 55 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Guilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
4193893345
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
1920422815
Health conditions studied
1
Description of health condition studied
The relationship between oral gabapentin and tramadol in acute pain after abdominal Histrectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
every 4 hours up to 24 hours
Method of measurement
Visual analogous score(0-10)
2
Description
Nausea and vomiting
Timepoint
Every 4 hours up to 24 hours
Method of measurement
Nausea and vomiting score (0-4)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Gabapanten 100 mg with 50 cc water 2 hours before surgery
Category
Prevention
2
Description
Intervention 2: Tramadol 100 mg with 50 cc water 2 hours before surgery
Category
Prevention
3
Description
Intervention 3: Placebo with 50 cc water 2 hours before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farnoush Farzi
Street address
Namjoo street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Farnoush Farzi
Position
Anesthesiologist/associated Professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1322 9524
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; Farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Farnoush Farzi
Position
Anesthesiologist/Assistant proffessor
Other areas of specialty/work
Street address
Alzahra Hosital
City
Rasht
Postal code
4139638459
Phone
+98 13 1322 9524
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 1321 0434
Fax
+98 13 1324 5132
Email
arcguilan1392@gmail.com; farnoush_farzi@yahoo.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)