Pain is prevalent after laparoscopic cholecystectomy surgery and it is necessary to find out a solution to control it. We evaluate the effect of Gabapantin in controlling the pain after laparoscopic cholecystectomy surgery. One of the advantages of this drug is that, it is used single- dose and reduces the request of other analgesics. It has some complication such as confusion and moving disorder and rare cases as leucopenia .70 individuals are randomly selected and divided into 2 groups. Plesebo is given to 35 individuals as a control group; The effect of Gabapantin 300 mg is assessed on the other 35 individuals. All 2 groups are identically anesthetised and are controlled each 2 hours to 18 hours and the results are listed in checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104132080N6
Registration date:2011-07-22, 1390/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-22, 1390/04/31
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of medical sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-08-21, 1390/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of gabapantin in the controling pain after laparoscopic cholecystectomy
Public title
The effect of gabapantin in the controling pain after laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age group of 20-60. Exclusion criteria: history of using analgesic and narcotic prior to the surgery; history of chronic lung and heart diseases; history of using Corticostroid; history of moving disorders; history of smoking; patient who use Gabapantin; history of sensitivity to Gabapantine.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Arak university of medical sciences
Street address
Alamol hoda street
City
Arak
Postal code
Approval date
2010-03-08, 1388/12/17
Ethics committee reference number
88-74-1
Health conditions studied
1
Description of health condition studied
colesystectomy laparascopy
ICD-10 code
K80
ICD-10 code description
Cholelithiasis
Primary outcomes
1
Description
pain
Timepoint
2 hours
Method of measurement
VAS and check list and physical examination
Secondary outcomes
1
Description
tremur
Timepoint
each 2 hours
Method of measurement
check list and physical examination
2
Description
nausea and vomitting
Timepoint
each 2 hours
Method of measurement
check list physical examination
3
Description
confusion
Timepoint
each 2 hours
Method of measurement
check list and physical examination
Intervention groups
1
Description
300 mg of gabapantin 1 hour before operation.
Category
Prevention
2
Description
placebo 1 hour before operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr. Afsaneh Norouzi
Street address
Valiasr hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr.Changizi Ashtiyani
Street address
Alamol hoda street
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak university of medical sciences
Full name of responsible person
Dr.afsaneh norouzi
Position
asistant professor, anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak city
Postal code
00988612224790
Phone
+98 86 1222 4790
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Dr. afsaneh norouzi
Position
assistant professor, anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
norouzi.a@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical sciences
Full name of responsible person
Farzaneh Alamshahi
Position
medical student
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
javdanegiii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)