Objective:Evaluation of the effects of gabapentin on pain relief after total abdominal hysterectomy.
Design:double blind randomized clinical trial.
Setting and conduct: candidates for total abdominal hysterectomy will be randomly assigned in two groups of intervention or placebo.In the intervention group; 800 miligrams of oral gabapentin and in the placebo group, placebo will be administered 1 hour before surgery . The method of anesthesia will be the same for both groups.After finishing the surgery and at the recovery room, 30 miligrams of pethidine will be injected for all subjects( point zero) and pain will be evaluated using Visual Analogue Scale (VAS). Then , in 2, 6, 12 and 24 hours after surgery, pain score according to VAS, and the severity of nausea and vomiting will be recorded.
Participants:Inclusion criteria:candidates for total abdominal hysterectomy; age between 35- 60 years old.
Exclusion criteria:history of known psychiatric disorders; drug abuse; patients with chronic pain.
Interventions:In the intervention group; 800 miligrams of oral gabapentin and in the placebo group, placebo will be administered 1 hour before surgery.
Main outcome: pain relief.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603172624N20
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2015-04-07, 1394/01/18
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of gabapentin on pain relief after total abdominal hysterectomy
Public title
Pain relief effects of gabapentin after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidates for total abdominal hysterectomy; age between 35- 60 years old.
Exclusion criteria:history of known psychiatric disorders; drug abuse; patients with chronic pain.
Age
From 35 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was performed as stratified block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran.University of Medical Sciences
Street address
Hemmat highway, Chamran Cross
City
Tehran
Postal code
Approval date
2014-10-21, 1393/07/29
Ethics committee reference number
93/د/105/ 3393
Health conditions studied
1
Description of health condition studied
Pain after hysterectomy
ICD-10 code
N00-N99
ICD-10 code description
Diseases of the genitourinary system
Primary outcomes
1
Description
Pain .
Timepoint
2, 6, 12 , 24 hours.
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gabapentin administration 1 hour before surgery.
Category
Treatment - Drugs
2
Description
Control group: placebo administration 1 hour before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross Road.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Hemmat High way, Junction of Chamran Highway.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross Road.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross Road.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross Road.
City
Tehran
Postal code
Phone
+98 21 5563 3244
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)