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The evaluation of success rate of two different methods of ilioinguinal–iliohypogastric nerve block for inguinal surgery in children

Protocol summary

Summary
120 patients, 3-11 years old, with American society of Anesthesiologists (ASA) status I and II, undergoing inguinal hernia repair, chryptorchidism, ...were prospectively enrolled in this study. Two different anatomic locations for ilioinguinal nerve block will be compared. In first group the landmarks will be anterior superior iliac spine and umbilicus, the injection site will be proximal 1/4 of the distance between ASI and umbilicus, the direction of needle (short bevel needle, 22-25 G ) will be the same side mid inguinal ligament. In second group landmarks will be anterior superior iliac spine and ilium bone, the injection site will be one cm medial and one cm superior to ASI, the drug of choice will be Bupivacaine %25, 0.4 ml/kg in both groups. The hemodynamic changes will be determined every 15 minutes during operation. If hemodynamic changes will be more than 10% of basic ones then fentanyl 1µg/kg will be injected and the time will be noted. 20 min after block the isoflorane percentage will be decreased. In successful blocks there will be no changes in hemodynamic. The hemodynamic changes, will be determined every 15 min during first postoperative 4 hours. The post-operative pain will be evaluated by Wong-Baker Face Pain Scale (FPS). If the pain score will be more than 2, the patients will be received acetaminophen 20 µg/kg and the time will be noted. The aim of this study is to compare the effects of two methods of ilioinguinal-illiohypogastric nerve block in children under 12 years old (Tabriz Children Hospital) on postoperative analgesia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903084041N2
Registration date: 2011-04-14, 1390/01/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-14, 1390/01/25
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2010-04-19, 1389/01/30
Expected recruitment end date
2011-01-19, 1389/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of success rate of two different methods of ilioinguinal–iliohypogastric nerve block for inguinal surgery in children
Public title
Ilioinguinal nerve block for inguinal surgery in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children with ASA I,II; 3-11 years old; candidated for lower abdominal surgeries. Exclusion criteria: contraindication to illioinguinal/illiohypogastric nerve block, failed blocks, known allergy to any of the study drugs.
Age
From 3 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Vice Chancellor for Research, Tabriz University Of Medical Sciences
Street address
Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2010-06-21, 1389/03/31
Ethics committee reference number
5/4/3826

Health conditions studied

1

Description of health condition studied
ilioinguinal block
ICD-10 code
K40.2
ICD-10 code description
Bilateral inguinal hernia, without obstruction or gangrene

2

Description of health condition studied
ilioinguinal block
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
pain
Timepoint
2-4-6-8 hr postoperative
Method of measurement
face pain scale

Secondary outcomes

1

Description
analgesic usage, total dose of analgesic
Timepoint
2-4-6 hr
Method of measurement
face pain scale>5

Intervention groups

1

Description
First group: the injection site for ilioinguinal nerve block will be proximal 1/4 of the distance between anterior superior iliac spine and umbilicus.
Category
Treatment - Other

2

Description
Second group: the injection site will be one cm medial and one cm superior to anterior superior iliac
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Tabriz Children Hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Tabriz University Of Medical Sciences
City
Tabriz
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, Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com , seidhejazie@tbmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com , seidhejazie@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com , seidhejazie@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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