Evaluation of the effect of ilio-inguinal block iliohypogastric by Landmark method with different doses of ropivacaine on intra and postoperative analgesia in children with inguinal hernia.
Evaluation of the effect of ilio-inguinal block iliohypogastric by Landmark method with different doses of ropivacaine on analgesia during and after surgery in children with inguinal hernia.
Design
Double-blind clinical trial with three parallel groups, randomized by simple randomization method. Sample size in each group 21, total 63 patients.
Settings and conduct
Children 1 to 7 years old who are candidates for unilateral inguinal hernia surgery are admitted to Bahrami Hospital. Conscious consent is obtained from the patient's parents. Patients are randomly assigned to group 1,2 or 3. After induction of anesthesia and vital signs recording , ilioinguinal iliohypogastric block is performed in group 1 with a dose of 0.1, in group 2 with a dose of 0.2, in group 3 with a dose of 0.3 ml / kg ropivacaine 0.2% by Landmark single injection method. Immediately after the surgical incision, the patient's vital signs are re-recorded. After the operation, the severity of the patient's pain is assessed in recovery, and the type and dose of analgesia prescribed are recorded in the recovery and surgery ward. The study is double-blind. The patient and the anesthesiologist and the data analyzer do not know which group the patient is in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 1 to 7 years old with no history of disease and ASA1,2 classification, candidate for unilateral inguinal hernia surgery
Conditions of non-entry: dissatisfaction of the patient's parents or legal guardian, allergy to local anesthetics, use of any analgesic.
Intervention groups
The patients are allocated in three groups:
1. Ilioinguinal iliohypogastric block with 0.1 ml/kg ropivacaine 0.2%
2. Ilioinguinal iliohypogastric block with 0.2 ml/kg ropivacaine 0.2%
3. Ilioinguinal iliohypogastric block with 0.3 ml/kg ropivacaine 0.2%
Main outcome variables
Mean arterial pressure;
Heart rate;
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201126049500N1
Registration date:2022-01-03, 1400/10/13
Registration timing:prospective
Last update:2022-01-03, 1400/10/13
Update count:0
Registration date
2022-01-03, 1400/10/13
Registrant information
Name
Bita Malekianzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2285 1471
Email address
bmalekianzadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ilio-inguinal block iliohypogastric by Landmark method with different doses of ropivacaine on intra and postoperative analgesia in children with inguinal hernia.
Public title
The effect of ilio-inguinal block of iliohypogastric on analgesia in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 1-7 years old
Candidate for unilateral inguinal hernia repair
ASA class 1,2
In Bahrami Children hospital
Exclusion criteria:
Dissatisfaction of Parents or legal guardian of the patient
Allergy to local anesthetic drugs
Peripheral nerve block contraindication
Intermittent or continuous consumption of any type of analgesics
Age
From 1 year old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be identified by the Randomization (Restricted Randomization) block method with 6 blocks and using a random number table of Random Allocation Software.
Random allocation software will be used to generate random sequences by blocking method. Allocation concealment will be used to execute random sequences on participants. Each random sequence generated will be recorded on a card and the cards will be sealed in opaque envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface, and finally the letter envelopes are glued and placed in a box, respectively. Registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The patient does not know which group he is in. The researcher is an anesthesiologist who performs the nerve block and knows which group the patient is in. The person who monitors the patient and evaluates the outcome is an anesthesia nurse who does not know the patient group.
the data analyzer also does not know the patient group. The group number is recorded in the patient information sheet and the type of intervention of each group is not recorded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Children's Medical Center, Tehran University of Medical Sciences
Street address
Tehran, Ghods Town, Iran Sima St., between Flamak and Zarafshan, Headquarters of the Ministry of Health, Treatment and Medical Education
City
Tehran
Province
Tehran
Postal code
1419943471
Approval date
2021-08-21, 1400/05/30
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.100
Health conditions studied
1
Description of health condition studied
Intraoperative and postoperative pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Intraoperative and postoperative in recovery
Method of measurement
Intraoperative: 20% increase in heart rate or mean arterial pressure. Postoperative: flacc pain score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Children 1 to 7 years old undergoing unilateral inguinal hernia surgery, ilio-inguinal iliohypogastric block with a dose of 0.1cc / kg ropivacaine 0.2%
Category
Treatment - Drugs
2
Description
Intervention group: Children 1-7 years old undergoing unilateral inguinal hernia surgery, ilioinguinal iliohypogastric block with 0.2 cc/kg ropivacaine 0.2%
Category
Treatment - Drugs
3
Description
Intervention group: Children 1-7 years old undergoing unilateral inguinal hernia surgery, ilioinguinal iliohypogastric block with 0.3 cc/kg ropivacaine 0.2%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Bita Malekianzadeh
Street address
Damavand
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7301 3000
Email
malekian.bita@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Street address
Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Fax
Email
malekian.bita@yahoo.com
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
Damavand
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7301 3000
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
Damavand
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7301 3000
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
Damavand
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7301 3000
Email
malekian.bita@yahoo.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