The purpose of this study is Comparison of low dose Pregabalin versus placebo on postoperative pain reduction in Laparoscopic Cholecystectomy patients. In this randomized, double blind clinical trial, a number of 172 patients, 20 – 60 years old inclusion criteria: candidate for elective laparoscopic Cholecystectomy; lack of severe systemic and mental disease; consent to take part in the study and exclusion criteria: history of drug allergy; opiate use; sedative use enrolled in study. They are randomly divided into two groups: Pregabalin and placebo. Thirty min before surgery study group takes 150 milligram Pregabalin orally and the control group received placebo orally with a glass of water. Laparoscopic Cholecystectomy is performed by one surgeon with same surgical technique under general anesthesia at the end of surgery after transferring to the ward, four, six and 24 hours after surgery pain measure and record by collaborator who does not know about grouping by using a visual index (Visual Analogue Scale) and analyzed
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312041617N8
Registration date:2014-06-15, 1393/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-15, 1393/03/25
Registrant information
Name
Mansour Choubsaz
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 83 1724 6708
Email address
mchoubsaz@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences Kermanshah
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of low-dose pregabalin versus placebo on pain relief after surgery in Laparoscopic Cholecystectomy patients
Public title
Comparison of low-dose pregabalin versus placebo on pain relief after surgery in Laparoscopic Cholecystectomy patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidate for elective laparoscopic Cholecystectomy; lack of severe systemic and mental disease; consent to participate in the study
Exclusion criteria: history of drug allergy; opiate use; sedative use
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
172
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
Ethic Committee of Kermanshah University of Medical Sciences
Street address
Ethic Committee of Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
Approval date
2013-11-06, 1392/08/15
Ethics committee reference number
33822
Health conditions studied
1
Description of health condition studied
Epigastric pain
ICD-10 code
R10.1
ICD-10 code description
Pain localized to upper abdomen
Primary outcomes
1
Description
pain
Timepoint
4,6,24 houres
Method of measurement
Visual analogue score
Secondary outcomes
empty
Intervention groups
1
Description
Pregabalin 150 mg oral tablet with a glass of water one hours before surgery
Category
Prevention
2
Description
Placebo oral tablet with a glass of water one hour before surgery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah University of Medical Sciences , Shahid Beheshti Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Nikbakhat
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Imam Reza Hospital
Full name of responsible person
Somayeh Mohammadi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Departement of Anesthesia and Intensive care, Imam Reza Hospital
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Reza Hospital
Full name of responsible person
Mansour Choubsaz
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard
City
Kermanshah
Postal code
6718938179
Phone
+98 83 1724 6708
Fax
+98 83 1724 4969
Email
mchoobsaz@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)