Evaluation of the Impact of caudal block anesthesia on the postoperative complications of hypospadias repair in children 6 months to 15 years old: a randomized clinical trial
Evaluation of the effect of the caudal epidural block on the outcome of hypospadias repair in boys 6 months to15 years.
Design
Two arm parallel-group double-blinded randomized clinical trial on 60 patients.
Settings and conduct
Boys with hypospadias will be assessed for eligibility. The study will take place at Al-Zahra Hospital, Isfahan, Iran. The patients will be randomized into two groups. In the case group, the caudal block will be performed following the surgery in addition to the general anesthesia. In the control group, only general anesthesia will be performed. The caudal block will be performed after the surgeon leaves the operating room.
Participants/Inclusion and exclusion criteria
Boys aged 6 months to 15 years who are candidates for hypospadias repair surgery.
Intervention groups
60 patients will be recruited in the study. The patients will be randomized into two groups: patients who underwent general anesthesia alone (control) and patients who underwent general anesthesia and caudal block anesthesia (case).
Main outcome variables
The complication rate of hypospadias repair
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200124046243N1
Registration date:2021-05-01, 1400/02/11
Registration timing:registered_while_recruiting
Last update:2021-05-01, 1400/02/11
Update count:0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
Saeid Haghdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81161
Email address
saeed_haghdani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Impact of caudal block anesthesia on the postoperative complications of hypospadias repair in children 6 months to 15 years old: a randomized clinical trial
Public title
caudal block anesthesia in hypospadias repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
boys
candidate for hypospadias repair
age between 6 month and 15 years
Exclusion criteria:
two stage hypospadias repair
history of previous surgery
history of spinal cord anomaly
history of diabet
history of other congenital defects
history of bleeding diathesis
history of drug allergy to bupivacaine
not using anticoagulants or antiplatelets
Age
From 6 months old to 15 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomized into two groups. Randomization will be performed by Random Allocation Software version 1.0.0. this software has been developed by M. Saghaei, MD, department of anesthesia, Isfahan University of Medical Science, Isfahan, Iran. (more about the software: https://pubmed.ncbi.nlm.nih.gov/15535880/). Blocks with an equal size of 6 will be used (View menu > Options > Equal size> 6). After every block, the number of participants in each group would be equal.
ُThe researcher will contact the patients' parents and the patient will receive a closed envelope that contains the code based on the allocated group. The closed envelope will be given to the anesthesiologist in the operating room. The anesthesiologist will perform the anesthesia based on the code. Thus, the surgeon and the patients will not have information about the group allocation.
(Download the software from here: https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html#Options)
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blinding will be performed for the participants and the surgeon. The closed envelope will be given to the anesthesiologist in the operating room. The caudal block will be performed after the operation based on the code of the patients in the envelope and the surgeon and the patients will not have information about the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Isfahan university of Medical Science
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
1234567890
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.MUI.MED.REC.1398.080
Health conditions studied
1
Description of health condition studied
hypospadias
ICD-10 code
Q54
ICD-10 code description
Hypospadias
Primary outcomes
1
Description
hypospadias surgery complications
Timepoint
1st week, 1st Month and 6th month after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Caudal Epidural Block anesthesia plus general anesthesia. caudal anesthesia is performed, using small needle (24-27 G) by injecting 0.5 mg/Kg of 0.125% Marcaine. Induction of anesthesia is done with thiopental sodium (5 mg/kg), atracurium (0.6 mg/kg), fentanyl (2 microg/kg), and morphin (0.1 mg/kg).During surgery, anesthesia is continued with 1.25 % isofluran gas.
Category
Treatment - Other
2
Description
Control group: general anesthesia
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Farshid Alizadeh
Street address
Sofeh street
City
Isfahan
Province
Isfehan
Postal code
8173945486
Phone
+98 31 3628 4662
Email
saeed_haghdani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Bahram Nasr
Street address
Hezar Jarib
City
isfahan
Province
Isfehan
Postal code
1234567890
Phone
+98 31 3792 9001
Email
nasr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
saeid haghdani
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
1234567890
Phone
+98 31 3628 4662
Fax
Email
saeed_haghdani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeid Haghdani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hasheminejad Kidney Research Center (HKRC), Iran University of Medical Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 81161
Fax
Email
saeed_haghdani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeid Haghdani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hasheminejad Kidney Research Center (HKRC), Iran University of Medical Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 81161
Fax
Email
saeed_haghdani@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