The objective of this study is to examine the effect of Gabapentin on pain after hysterectomy. The inclusion criteria were: candidate for hysterectomy (elective), intact emotional and psychological health, duration of surgery and anesthesia up to 2 hrs, and patients cooperation. The exclusion criteria were: age over 60, past history of renal disease, seizures, diabetes (IDDM). Study sample was 60. All candidates were taken an informed consent and assigned randomly into two groups of cases (received 1200mg of Gabapenthin) and controls. The drug was prescribed an hour before the operation by a nurse. Both groups received general anesthesia. Then repeated doses were given 2 hr and 4 hrs after the operation. Pain severity was measured based on VAS scale. If the score was over 4, anesthesia dose of 25 mg of Pethidin was given intramuscularly. Severity of pain and emesis was recorded. VAS score and emesis-vomiting incidence were compared by statistical analyses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803061946N2
Registration date:2010-05-21, 1389/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Mandana Mansur Ghanaie
Name of organization / entity
Giulan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
m_m_ghanaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2010-02-19, 1388/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Gabapentin on pain reduction after hysterectomy abdominal
Public title
Effect of Gabapentin on pain reduction after hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for hysterectomy (elective), intact emotional and psychological health, duration of surgery and anesthesia up to 2 hrs, and patients cooperation. Exclusion criteria: age over 60, past history of renal disease, seizures, diabetes (IDDM).
Age
From 30 years old to 59 years old
Gender
Female
Phase
2
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
Vice Chancellor for research, Guilan University of Medical Sciences
Street address
Mellat Street, Namjoo Avenue
City
Rasht
Postal code
Approval date
2009-07-14, 1388/04/23
Ethics committee reference number
3092
Health conditions studied
1
Description of health condition studied
Other complications of spinal and epidural anaesthesia during the puerperium
ICD-10 code
O89.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during the puerperium
Primary outcomes
1
Description
pain reduction
Timepoint
2 hrs and 4 hrs after the operation
Method of measurement
questionnaire, cheklist of VAS scale
Secondary outcomes
1
Description
usage of narcotics
Timepoint
2hrs and 4hrs after the operation
Method of measurement
Questionnaire
2
Description
nausea and vomiting
Timepoint
q one hour for 4 hours then q four hours for 8 hours
Method of measurement
patient's record
Intervention groups
1
Description
Control: Placebo
Category
Placebo
2
Description
Intervention: Gabapenthin 1200mg Po
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
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, 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
Mandana Mansuor Ghanaie
Position
Assistant professor
Other areas of specialty/work
Street address
Reproduction Health Research Center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Giulan University of Medical Sciences
Full name of responsible person
Mandana Mansur Ghanaie
Position
Assistant professor
Other areas of specialty/work
Street address
Reproduction Health Research Center-Alzahra hospital-Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
m_m_ghanaie@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reproduction Health Research Center
Full name of responsible person
Seyede Fatemeh Dalil Heirati
Position
Bs in Midwifery
Other areas of specialty/work
Street address
Reproduction Health Research Center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)