The comparison between low dose of gabapentin and diclofenac on postoperative pain in patients undergoing abdominal hysterectomy with general anesthesia
The aim of this study is to compare the effect of low dose of gabapentin and diclofenac on postoperative pain in patients undergoing abdominal hysterectomy with general anesthesia. This study will be performed on 100 patients undergoing abdominal hysterectomy in Rasht Al-zahra hospital in 2012-2013. After obtaining written and informed consent women aged 35-55 years without underlying disease will be divided randomly into two groups of 50 persons. One group will be treated with 300 mg oral Gabapentin capsule and suppository placebo at 8, 16, 24 hours after surgery and another group will be treated with 100mg suppository diclofenac and oral placebo capsule at 8, 16, 24 hours after surgery. All patients will be treated by 0.5 mg/kg pethedin, after transfer to the ward. The drugs will be prescribed by nursery agent to patients. Any person who are involved as executive agents in this study, have no information about prescribed drugs. The severity of pain will be evaluated using visual analogs scale (VAS) score at 2, 4, 6, 12, 24 hours after surgery. Finally VAS score in both groups will be compared using statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111710089N2
Registration date:2013-05-12, 1392/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Roya Faraji Darkhaneh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
h_fertility@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research – Guilan university of medical sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between low dose of gabapentin and diclofenac on postoperative pain in patients undergoing abdominal hysterectomy with general anesthesia
Public title
Comparing low dose of gabapentin and diclofenac on posthysterectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: women's age between 35-55 years, informed consent – The exclusion criteria: past history of heart, lung, kidney, GI tract, liver and psychiatric disease, raised of intra-cranial pressure, hypertension, chronic pain disorder, previous surgery, prolonged surgery (upon 2 hours), emergent hysterectomy, infection and ileus after surgery.
Age
From 35 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is random and double-blind because of the main outcome ( determine severity of pain) is subjective, so we will omit the psychological effect of two different drug administration with this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Guilan University of Medical Sciences
Street address
Ethics Committee, Guilan University of Medical Sciences، Gaz Square
City
Rasht
Postal code
Approval date
2013-02-09, 1391/11/21
Ethics committee reference number
1910396402
Health conditions studied
1
Description of health condition studied
Postprocedural disorders of genitourinary system, not elsewhere classified
ICD-10 code
N99
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified
Primary outcomes
1
Description
Post-operative pain
Timepoint
2, 4, 6, 12, 24 hours after surgery.
Method of measurement
By using VAS SCORE
Secondary outcomes
1
Description
Frequency of nausea
Timepoint
2,4,6,12,24 hours after surgery.
Method of measurement
Question from patient
2
Description
Frequency of vomiting
Timepoint
2,4, 6,12, 24 hours after surgery.
Method of measurement
Question from patient
3
Description
Frequency of dizziness
Timepoint
2, 4, 6,12, 24 hours after surgery.
Method of measurement
Question from patient
4
Description
Frequency of time additive pethedin needed
Timepoint
2, 4, 6,12, 24 hours after surgery.
Method of measurement
Patient’s documents
Intervention groups
1
Description
Prescription of 100 mg rectal suppository diclofenac (Behvazan Pharmaceutical Company) plus oral placebo capsule (ُSobhan Pharmaceutical Company) to control group three times every eight hours .
Category
Treatment - Drugs
2
Description
Prescription of 300 mg oral gabapentin (Sobhan Pharmaceutical Company) plus rectal suppository placebo (Behvazan Pharmaceutical Company) intervention group three times every eight hours .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital, Guilan university of medical sciences.
Full name of responsible person
Roya Faraji darkhane
Street address
Alzahra Hospital, Namjoo Street
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
Abdolrasol Sobhani
Street address
Gaz Square, Vice Chancellor for research
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
Giulan University of Medical Sciences
Full name of responsible person
Faeze Fashkhami
Position
Associated professor-Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Alzahra hospital, Namjo street, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 911 334 1365
Fax
Email
h_fertility@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
Roya Faraji darkhane
Position
Associated professor, Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Alzahra hospital, Namjo street, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 911 131 1710
Fax
Email
Royafaraji1371@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nazli Peiraveian
Position
BS of Nursing
Other areas of specialty/work
Street address
Alzahra hospital, Namjo street, Reproductive Health Research Center
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)