The aim of this study was to compare the effects of pre- and post incisional infiltration of the surgical area with bopivacaine on cortisol (C) and prolactin (PRL) release and postoperative pain in patients undergoing inguinal hernia repair.In this clinical trial, 48 male patients, aged 20 to 50 years, undergoing inguinal hernia repair under spinal anesthesia were placed randomly into 2 groups. Local anesthesia was performed in group I patients (case) by 2 mg/kg ropivacaine.and group II patients (controls) did not received any local anesthetic.Plasma Cortisol and Prolactin concentration were compared in both group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107131106N4
Registration date:2011-08-29, 1390/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-29, 1390/06/07
Registrant information
Name
Zohreh Azarbad
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 2999
Email address
azarbad_zo@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan Univercity of medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2010-12-20, 1389/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of local anesthesia on Cortisol and Prolactin concentration in Inguinal Hernioraphy
Public title
Effects of local anesthesia on Cortisol and Prolactin concentration in Inguinal Hernioraphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : male patient with inguinal hernia with age between 20 to 50.
Exclusion criteria : Stuck and needed emergency hernia surgery patients; history of chronic diseases and people who regularly use opium or opiates morphine group
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
5th Km of Ghotbe Ravandi Bulv.
City
Kashan
Postal code
8713781147
Approval date
2009-11-01, 1388/08/10
Ethics committee reference number
3271
Health conditions studied
1
Description of health condition studied
ingunal hernia
ICD-10 code
k40-9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
Primary outcomes
1
Description
Prolactin levels
Timepoint
Before surgery - 3 hours after surgery
Method of measurement
Blood
2
Description
Cortisol levels
Timepoint
Before surgery - 3 hours after surgery
Method of measurement
Blood
Secondary outcomes
1
Description
Pain
Timepoint
Three hours after surgery
Method of measurement
Standard Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Local anesthesia by 2 mg/kg ropivacaine
Category
Treatment - Drugs
2
Description
Control group: did not received any local anesthetic
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr.Mehrdad Hosseinpour
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
5th Kilometer Ghotbe Ravandi Bulv.Kashan University of Medical Sciences
City
kashan
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
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
kashan Univercity of Medical Sciences
Full name of responsible person
Leila Ghafoor
Position
General Surgeon
Other areas of specialty/work
Street address
5th Kilometer Ghotbe Ravandi Bulv.Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1444 3298
Fax
Email
leila.ghafoor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Dr.Mehrdad Hosseinpour
Position
Pediatric Surgery
Other areas of specialty/work
Street address
5th Kilometer Ravand Bulv. Beheshti Hospital
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
hosseinpour_m@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Zohreh Azarbad
Position
Midwifery MSc
Other areas of specialty/work
Street address
City
kashan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)