Objectives: This study is aimed to compare the effect of oral pregabalin and placebo before surgery on post operative pain after laparoscopic Gastric Bypass surgery.
Design: Prospective randomized clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: Sixty patients, with age 18-50 yr; ASA Class I- II, undergoing laparoscopic Gastric Bypass surgery in Rasul Hospital during 2010-2011 , were included . Patients were randomized into two groups of 30 each, using a table of random numbers. Intervention: Study group , patients received 300 milligrams pregabalin and control group patients received 300 milligrams placebo within one hour before surgery. Main outcome measures (variables): VAS and PONV.
The medications are coded and delivered to the patients by and individual not aware of the research process. A blind stuff assessed VAS and PONV in each groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102255184N2
Registration date:2012-01-28, 1390/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-28, 1390/11/08
Registrant information
Name
Seyede Fateme Navadegi
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
navadegi@irimc.org
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2009-08-30, 1388/06/08
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of oral pregabalin on post operative pain after laparoscopic Gastric Bypass surgery
Public title
Effect of oral pregabalin on post operative pain after laparoscopic Gastric Bypass surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-50 yr; ASA Class I- II
Exclusion criteria: Systolic Blood pressure less than 90 mmHg; Substance abuse; Pregnancy and breast feeding; Nonsteroidal anti-inflammatory drugs sensitivity; Asthma and Allergic rhinitis, Peptic ulcer disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
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
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Poursina Ave.
City
Tehran
Postal code
Approval date
2010-02-01, 1388/11/12
Ethics committee reference number
43111
Health conditions studied
1
Description of health condition studied
Postoperative pain control
ICD-10 code
G89.11
ICD-10 code description
Postoperative acute pain control
Primary outcomes
1
Description
Pain score
Timepoint
At recovery, 30 minutes, 2,4,12 and 24 hours after surgery
Method of measurement
VAS
Secondary outcomes
1
Description
Opioid consumption
Timepoint
24 hours after surgery
Method of measurement
By PCA
2
Description
Nausea & vomiting
Timepoint
24 hours after surgery
Method of measurement
By asking the patient the question
Intervention groups
1
Description
In the study group, 300 milligrams pregabalin, one hour before surgery
Category
Treatment - Drugs
2
Description
In the control group, 300 milligrams placebo, one hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Hospital
Full name of responsible person
Mahzad Alimian
Street address
Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh MD.
Street address
Poursina St.
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, Tehran University of Medical Sciences and Health Services
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
Rasul Hospital
Full name of responsible person
Mahzad Alimian
Position
Assistant Professor
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
m-alimian@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Mahzad Alimian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
m-alimian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rasul Hospital
Full name of responsible person
Seyede Fateme Navadegan
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6650 9059
Fax
Email
navadegi@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)