Comparison of the effect of bilateral ilioinguinal block and rectal acetaminophen on postoperative pain in children undergoing bilateral inguinal hernia surgery
Determining the effect of bilateral ilioinguinal block and rectal acetaminophen on postoperative pain in patients undergoing bilateral inguinal hernia surgery
Design
This double-blind clinical trial, without control group, was randomized with parallel groups. This phase 3 study will be performed on 60 patients who are candidates for surgery.
Settings and conduct
The patient and the person collecting the information do not know the patient grouping. The nurse who records the patient's data during the operation and in the recovery is not at the patient's bedside at the beginning of the operation and does not know what procedure has been performed for the patient's analgesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients candidate for inguinal hernia surgery; being at the age of 1 to 6 years; class 1 and 2 anesthesia; with the consent to participate in the project; no history of sensitivity to local anesthetics. Non-inclusion criteria: seizure disorders; patients with mental disorders; gastrointestinal disorders; liver disease; history of seizures; weight more than 20 kg.
Intervention groups
In the intervention group of ilioinguinal block, after induction, the patient underwent ilioinguinal block with rupivacaine 0.2% underwent ultrasound and in the intervention group acetaminophen, rectal paracetamol at a dose of 40 mg / kg will be administered via nelaton. In performing ilioinguinal block, the child is placed in the supine position and after filling and dropping, a short 24G needle is used.
Main outcome variables
Postoperative pain using CHEOPS pain scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220526054992N1
Registration date:2022-07-01, 1401/04/10
Registration timing:prospective
Last update:2022-07-01, 1401/04/10
Update count:0
Registration date
2022-07-01, 1401/04/10
Registrant information
Name
Sajjad Sattari forough
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 0386
Email address
ssattari388@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-08-22, 1401/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of bilateral ilioinguinal block and rectal acetaminophen on postoperative pain in children undergoing bilateral inguinal hernia surgery
Public title
The effect of bilateral ilioinguinal anesthesia and acetaminophen on postoperative pain in children undergoing hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for inguinal hernia surgery
Being at the age of 1 to 6 years
Class 1 and 2 anesthesia
With the consent to participate in the project
No history of sensitivity to local anesthetics
Exclusion criteria:
Emergency surgery
History of seizures
History of allergy to local anesthetics
patients with mental disorders
gastrointestinal disorders
liver disease
history of seizures
weight more than 20 kg.
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups by 6-block method. Randomization is individual. Random numbers randomization tool.In this method, three allocations to the intervention group and three allocations to the control group are considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person collecting the information do not know the patient grouping. The anesthesia nurse, who records the patient's vital signs during the operation and in the recovery, is not at the patient's bedside at the time of the operation and does not know what procedure has been performed to relieve the patient's pain.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pediatric Medical Center-Tehran University of Medical Sciences
Street address
Central headquarters of Tehran University of Medical Sciences, Ghods street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-04-15, 1400/01/26
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.032
Health conditions studied
1
Description of health condition studied
Bilateral inguinal hernia surgery
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Pain severity after surgery
Timepoint
Immediately after surgery, 10 minutes and 15 minutes after surgery
Method of measurement
CHEOPS pain score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Patients who undergo bilateral ilioinguinal block before surgery.
Category
Treatment - Surgery
2
Description
Intervention group2: Patients receiving rectal acetaminophen before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Children's Medical Center
Full name of responsible person
Bita Malekian Zadeh
Street address
No 62, Dr. Mohammad Gharib St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6405 3334
Fax
+98 21 6640 5373
Email
vcr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotuhi
Street address
Vice Chancellor for Research and Technology; sixth floor; Central University Organization; Qods St.; Keshavarz Boulevard, ,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6405 3334
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 62, Children's Medical Center, Dr Gharib St, Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 912 957 7267
Email
malekian.bita@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 62, Children's Medical Center, Dr Gharib St, Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 912 957 7267
Email
malekian.bita@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No 62, Children's Medical Center, Dr Gharib St, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 912 957 7267
Email
malekian.bita@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Not all data can be shared.The results of the analysis based on the main aim of the study and the demographic information of the patients can be shared.
When the data will become available and for how long
2 months after article publication.
To whom data/document is available
Doctors, nurses, clinical researchers
Under which criteria data/document could be used
All analysis are possible on the data.
From where data/document is obtainable
Dr Mirsajjad Sattari forogh
What processes are involved for a request to access data/document