Determining the effect of pregabalin on pain after inguinal hernia repair surgery by open method:
Design
There were 30 patients in the control group who were separated from the control group by dropping a coin. They received 75 mg of pregabalin 1 hour before the operation and 12 hours after it, and the control group was given a placebo at same time. Patient pain was measured at0, 6, 12, 24 and 48 hours after surgery
Settings and conduct
The experiment was performed in Shahid Beheshti Hospital of Kashan. The people who gave medicine and placebo to the patients and the patients and the analyzer became blind were 30 people in the control group who received 75 mg of pregabalin 1 hour before the operation and 12 hours after it and the control group. At the same time, a placebo was given and then the patient's pain was measured at 6, 12, 24 and 48 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: open inguinal hernia repair surgery. Having an age between 20 to 65 years.
Exclusion criteria: Pregnancy, history of pregabalin allergy, history of pregabalin treatment, history of syndrome
Chronic pain and analgesia, alcohol and drug addiction, pethidine allergy,
Intervention groups
There were 30 patients in the control group who received 75 mg of pregabalin 1 hour before and 12 hours after the operation and the control group was given a placebo at the same time.
Main outcome variables
Age; sex;dosage of pethidine use; nausea and vomiting;pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200731048260N1
Registration date:2020-10-30, 1399/08/09
Registration timing:retrospective
Last update:2020-10-30, 1399/08/09
Update count:0
Registration date
2020-10-30, 1399/08/09
Registrant information
Name
Benyamin Seyfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2259 6152
Email address
seyfari@ptsoc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
2020-03-05, 1398/12/15
Actual recruitment end date
2020-07-20, 1399/04/30
Trial completion date
2020-07-20, 1399/04/30
Scientific title
Evaluation the analgesic effect of Pergabalin on postoperative pain : A double blind randomized clinical trial
Public title
The analgesic effect of Pergabalin on post operative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients candidate for open inguinal hernioraphy
patients between 20 to 65 years old
Exclusion criteria:
pregnancy
sensitivity to pergabalin
addiction to drugas or alcohol
sensitivity to pethedin
uncontroled blood pressure
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We used Excel , ( Random between ) , to divide 60 numbers in two groups and then used that order for patients to divide them in two different categories
Blinding (investigator's opinion)
Double blinded
Blinding description
patients were told there is an aditional medication to evaluate how pain reponse to it
the anilizers didnt know the group of patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, School of Medicine and Dentistry-Kashan University of Medi
Street address
General surgery group-kashan university of medical Sciences-ghotb ravandy bolvared
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.132
Health conditions studied
1
Description of health condition studied
patients candidate for open inguinal herniorrhaphy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the amount of pain after inguinal herniorrhaphy
Timepoint
mearement of patients painimmediately after herniorrhaphy and 6,12,24,48 h after surgery
Method of measurement
Comparing the amount of pethedin recieved - Comparing pain rates by V.A.S (Visual Analog Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregabalin capsules (75 mg )c from Sami Saz Company were given to patients one hour before and 12 hours after surgery.
Category
Treatment - Drugs
2
Description
Control group: we gave placebos one hour before and 12 hours after surgery to this group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital of Kashan
Full name of responsible person
Benyamin Seyfari
Street address
unit 10 , apartment No 28 , Biglar Pur west alley, jahantab street, gheytarieh
City
Tehran
Province
Tehran
Postal code
1939883613
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Deputy of research and technology.Kashan university of medical scienc.ghotbe ravandi boulevard
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5557 8010
Email
education @kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 . Apartment number 28.Biglarpour west alley. jahantab street . Gheytarie south
City
Tehran
Province
Tehran
Postal code
1939883613
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 . Apartment number 28.Biglarpour west alley. jahantab street . Gheytarie south
City
Tehran
Province
Tehran
Postal code
1939883613
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Benyamin Seyfari
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Unit 10 . Apartment number 28.Biglarpour west alley.jahantab street . Gheytarie south
City
Tehran
Province
Tehran
Postal code
1939883613
Phone
+98 21 2259 6152
Email
benyaminseyfari1369@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available