Comparison of efficacy of transversus abdominis plane block and iliohypogastric/ilioinguinal ultrasonic block for postoperative pain management in pediatric patients
Comparison of the efficacy of transverse abdominal muscle block with ileohypogastric / ileoengyngal block using ultrasound in postoperative pain management
Design
Clinical trial with control group, with parallel group design, triple blind, randomized with 50 subjects
Settings and conduct
This study will be performed on children in need of inguinal hernia repaired on Tabriz Children Hospital Operating Room and only the hospital operating room will be informed of the groupings The statistical analyzer is also unaware of the block method and derived sequence and therefore the study will be a triple blind.The study will be designed and conducted based on the descriptions given in the description of how to become blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria;
6-12 year-old children;
Children with ASA Class I and II require inguinal hernia repair;
exclusion criteria;
parental dissatisfaction with regional block;
and allergy to topical anesthesia.
Intervention groups
Intervention group: Children who will undergo ultrasound guide transverse abdominal muscle block for surgery, In the intervention group, the needle was inserted medial to lateral fashion and after reaching the tip of the needle to the fascia between the IO and TA muscles 0.2ml / kg of 0.25% bupivacaine solution (ie 0.5mg / kg) are injected around the nerves.
Control group: Children will undergo ultrasonic guided ileohepogastric / ileoengyngal block.
Main outcome variables
The amount of pain;
The amount of used analgesic drug;
The time it takes to do blocking;
The time that patient need the first analgesic drug.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190730044383N1
Registration date:2020-02-18, 1398/11/29
Registration timing:registered_while_recruiting
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
Arefe Khanoghlan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 1333 8507
Email address
arefe6876@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-18, 1398/06/27
Expected recruitment end date
2020-09-17, 1399/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of transversus abdominis plane block and iliohypogastric/ilioinguinal ultrasonic block for postoperative pain management in pediatric patients
Public title
Comparison of efficacy of different nerve block with ultrasonic guide for postoperative pediatric pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6-12 years old
Children with ASA Class I and II requiring inguinal hernia repair
Exclusion criteria:
Parental dissatisfaction with performing regional block
Allergy to local anesthesia will be
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be a layer randomization such that depending on patient ID , if the ID is an even number, ultrasound guidance TAP block will be conducted for him/her and if it is odds number, the ultrasound guidance IIN / IHN block will be done.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The head of the operating room of the Tabriz Pediatric Hospital will be aware of this. During surgery and after recovery, the examiner will examine the patient and record the relevant criteria for the patient without knowing which treatment method is selected. The statistical analyzer is also unaware of the block method and therefore will be a triple blind study.The surgery was the same in both groups but the analgesic method differed in both groups. depending on patient ID , if the ID is an even number, ultrasound guidance TAP block will be conducted for him/her and if it is odds number, the ultrasound guidance IIN / IHN blockwill be done.
And since the anesthesiologist will proceed with the procedure according to the file number, so he or she will not be aware of the child's grouping, so the parents of the child are also unaware of the type of block.
Comparison of the efficacy of abdominal transverse muscle block block with ileohypogastric / ileoengyngal block
ICD-10 code
ندارد
ICD-10 code description
ندارد
Primary outcomes
1
Description
The amount of pain
Timepoint
6 to 12 months after surgery
Method of measurement
visual analogue scale
2
Description
The amount of used analgesic drug
Timepoint
recovery period
Method of measurement
Questionnaire
3
Description
The time it takes to do the block
Timepoint
during the procedure
Method of measurement
Questionnaire
4
Description
The time that patient needs the first analgesic drug
Timepoint
during recovery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group ultrasound probe is placed transversely in midaxillary line, between iliac crest and inferior rib margins. After ultrasonographic view of abdominal wall layer is obtained , Needle guge of 20 or 22 (according to the child's age) is inserted medial to the lateral plane and after reaching the needle tip to the fascia between the IO and TA muscles 0.4ml / kg of 0.25% bupivacaine solution (ie 1mg). / kg) will be injected. In case of bilateral inguinal hernia repair (or surgical incision beyond the midline of the body), in each case, the above-mentioned area blocks will be bilateral. In all of the above, the dose of topical anesthesia drugs should not exceed toxic dosage (2mg / kg bupivacaine)
Category
Treatment - Surgery
2
Description
Control group: In this group the ultrasound probe is placed transversely in center of imaginary line between anterior superior iliac spine and navel and the lateral end of the probe adheres to the anterior superior iliac spine Needle score of 20 or 22 (according to child's age) is in-plane medially lateral to body and after needle tip reached to fascia between IO and TA muscles 0.2ml / kg of 0.25% bupivacaine solution (ie 0.5 mg / kg) will be injected in the vicinity of the above nerves and a "Kayak" view or mark will be obtained.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Arefe Khanoghlan
Street address
Golghast St., Azadi St Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
arefe6876@gmail.com
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Ali Akbar Sharabiyani
Street address
Golghast St., Azadi St ،Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
sharabiani48@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Behzad Sharbiani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Golghast St., Azadi St ،Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
sharabiani48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arefeh Khanghlan
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Golghast St., Azadi St ،Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 3176
Email
Arefe6876@gmil.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ali Meshkini
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golghast St., Azadi St ،Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
Meshkinia@gmail.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