This study is designed to survey gabapentin analgesic effect on post-abdominal hysterectomy pain. Fifty patients aged 35-50 years candidate for abdominal hysterectomy will be included in this study. After signing the informed consent, the patients will be randomly assigned into two groups. The intervention group will receive 1200mg gabapentin and the control group 1200mg placebo. Then, all patients will undergo the operation with the same procedure under the same anesthesia method. The pain will be measured at 2, 6, 12, and 24 hours after the operation with visual analogue scale. Then, the patients will receive 5mg morphine if the pain score was more than 4. Pain intensity, the amount of morphine consumed, nausea, vomiting, and light headedness will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903112967N2
Registration date:2010-06-01, 1389/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-01, 1389/03/11
Registrant information
Name
Fatemeh Foroozanfar
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1446 0180
Email address
forozanfar_f@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancelor for Research Kashan University of Medical Sciences
Expected recruitment start date
2010-05-16, 1389/02/26
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The post operative analgesic effect of gabapentine in patients undergoing abdominal hysterectomy.
Public title
The post operative analgesic effect of gabapentine in patients undergoing abdominal hysterectomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 35-50 years, candidate for hysterectomy
Exclusion criteria: Allergy to morphine or gabapentine, chronic use of analgesic drugs or steroid, drug addiction, history of cardiovascular, hepatic, respiratory, or renal diseases, presence of asthma or chronic pain syndrome
Age
From 35 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Kashan University of Medical Sciences
Street address
Vice-chancelor for Research,Ghotbe Ravandi Blvd,Kashan
City
Kashan
Postal code
Approval date
2010-03-16, 1388/12/25
Ethics committee reference number
7911
Health conditions studied
1
Description of health condition studied
post abdominal hysterectomy pain
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified
Primary outcomes
1
Description
post-abdominal hysterectomy pain
Timepoint
2, 6, 12, 24 hours after operation
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Morphine consumption
Timepoint
2, 6, 12, 24 hours after operation
Method of measurement
Number of morphine ampules consumption
Intervention groups
1
Description
Gabapentine, 1200mg orally one hour before operation
Category
Treatment - Drugs
2
Description
Placebo, 1200mg orally simillar to gabapentin exception for effective material one hour before operation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabih khani Maternity Hospital
Full name of responsible person
Dr. Fatemeh Foroozanfard
Street address
Shabih khani Maternity Hospital, Shahid Beheshti Street
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancelor for Research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Vice-chancelor for Research, Ghotbe Ravandi
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancelor for Research, Kashan University of Medical Sciences