This is a double-blinded clinical trial conducted on patients who needed inguinal hernia surgery.
We recruited patients over 10 and all recurrent, strangulated, sliding, or gangrene hernias were excluded from study. After Ethical committee approval, 80 patients were allocated into 2 groups using block-randomized and also informed consent were taken. Using interview, demographic data was collected.
Bupivacaine 0.5 Mg / kg diluted in 5 ml normal saline injected subcutaneously in intervention group.
The placebo group received only 5 cc of normal saline. Within 24 hours and 48 hours after surgery patients pain measured using visual analogue scale in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101304808N3
Registration date:2011-04-30, 1390/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-30, 1390/02/10
Registrant information
Name
Mozhdeh Zarei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1278
Email address
mozh.zarei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdestan University of Medical Science
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2009-03-21, 1388/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bupivacaine local anesthetic effect on after inguinal hernia pain relief
Public title
Local anesthesia on pain after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: patients who require Inguinal hernia surgery; Age over 10 years
exclusion criteria: recurrence of hernia; sliding hernia
strangulation - gangrene complications
Age
From 11 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Kurdistan University of Medical Sciences
Street address
sanandaj Kurdistan University of Medical Sciences
City
sanandaj
Postal code
66117713446
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
24/4/87 پ14 ع 3755
Health conditions studied
1
Description of health condition studied
pain after inguinal hernia surgery
ICD-10 code
k40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
pain after inguinal hernia surgery
Timepoint
0,24, and 48 hours later
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention: bupivacain 0.5 Mg / kg add to normal saline 5 ml was subcutaneous injection.
Category
Treatment - Drugs
2
Description
control:
only 5 cc of normal saline was injected.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
Mozhdeh Zarei
Street address
Pasdaran Blvd, Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan university of Medical Science
Full name of responsible person
Fardin Gharibi
Street address
Sanandaj
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan university of Medical Science
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
Kurdistan University of Medical Science
Full name of responsible person
Fardin Gharibi
Position
MSc
Other areas of specialty/work
Street address
Pasdaran Blvd,Kurdistan University of Medical Sciences, Sanandaj
City
Sanandaj
Postal code
00988716617713446
Phone
+98 87 1328 5912
Fax
+98 87 1666 4654
Email
fardin_gharibi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Science
Full name of responsible person
Jafar Mobaleghi
Position
Surgical specialist
Other areas of specialty/work
Street address
Pasdaran Blvd, Kurdistan University of Medical Sciences, Sanandaj
City
sanandaj
Postal code
00988716617713446
Phone
+98 87 1613 1278
Fax
+98 87 1666 4654
Email
jafar.mobaleghi@muk.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdestan University of Medical Sciences
Full name of responsible person
Mozhdeh zarei
Position
MSc
Other areas of specialty/work
Street address
Pasdaran Blvd, Kurdestan University of Medical Sciences, Sanandaj
City
Sanandaj
Postal code
00988716664654
Phone
+98 87 1613 1278
Fax
+98 87 1666 4654
Email
mozh.zarei@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)