Clinical trial comparison of ilioinguinal and iliohypogastric never blocks with subfascial infiltration with bupivacaine in postoperative pain in hernioharphy surgery
The aim of this study is to compare ilioinguinal and iliohypogastric never blocks with subfascial infiltration with bupivacaine in postoperative pain in herniorhaphy surgery.In this clinical trial study ,99 patients candidate for herniorrhaphy entered the study.Inclusion criteria : Inguinal hernia without symptom; 20-75 years; ASA I and II; no history of cardiac disease; pulmonary and renal disease; no insensitivity to Bupivacain and petedin; no analgesia for routine.Exclusion criteria:Inguinal hernia complicated; allergy to bupivacaine or petedine; ASA class higher than 2; renal failure; a complication of the surgery; a previous or current medical conditions; drug use prior to surgery; patients who are not able to communicate.After the end of surgery, patient were randomly( double blinde) divided into three groups.In first group ilioinguinal and iliohypogastric nerve block obtained with 10cc of 0.5 % bupivacaine , the second group undewant subfascial instillation with 10 cc of 0.5 % bupivacain and no infiltration was performed in the last group .The pain score was evaluated by VAS immediately ,6 and 12 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030220258N4
Registration date:2016-03-21, 1395/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-21, 1395/01/02
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparison of ilioinguinal and iliohypogastric never blocks with subfascial infiltration with bupivacaine in postoperative pain in hernioharphy surgery
Public title
Clinical trial comparison of ilioinguinal and iliohypogastric never blocks with subfascial infiltration with bupivacaine in postoperative pain in hernioharphy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Inguinal hernia without symptom; 20-75 years; ASA I and II; no history of cardiac disease; pulmonary and renal disease; no insensitivity to Bupivacain and petedin; no analgesia for routine
Exclusion criteria:Inguinal hernia complicated; allergy to bupivacaine or petedine; ASA class higher than 2; renal failure; a complication of the surgery; a previous or current medical conditions; drug use prior to surgery; patients who are not able to communicate
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences and Health Services
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Postal code
848176941
Approval date
2012-09-03, 1391/06/13
Ethics committee reference number
91-132-6
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40.3
ICD-10 code description
Unilateral or unspecified inguinal hernia, with obstruction, without gangrene Inguinal hernia (unilateral): causing obstruction incarcerated irreducible strangulated without gangrene
Primary outcomes
1
Description
Pain
Timepoint
after operation,6 hours after operation,12hours after operation,24 hours after operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
In first group ilioinguinal and iliohypogastric nerve block obtained with 10cc of 0.5 % bupivacaine
Category
Treatment - Drugs
2
Description
The second group undewant subfascial instillation with 10 cc of 0.5 % bupivacain
Category
Treatment - Drugs
3
Description
no infiltration was performed in the last group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Shahin Fateh
Street address
Arak, Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Arak, Sardasht, Basij Square, Payambar Azam Complex, Reaserch Center
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Valiasr Hospital
Full name of responsible person
Dr Shahin fateh
Position
Sub-specialist in thorax surgery
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
dr.nourozi@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medicine department
Full name of responsible person
Dr Shahin Fateh
Position
Sub-specialist in thorax surgery
Other areas of specialty/work
Street address
Arak, Sardasht, Basij square, Payambar Azam complex, Reaserch center
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
dr.norouzi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital
Full name of responsible person
Dr Shahin Fateh
Position
Sub-specialist in thorax surgery
Other areas of specialty/work
Street address
Arak, Sardasht, Basij square, Payambar Azam complex, Reaserch center
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)