Comparison of intra and postoperative analgesic effect of caudal block and ultrasound guided pudendal block in children aged 1-7 years undergoing hypospadias surgery
Comparison of intra and postoperative analgesic effect of caudal block and ultrasound guided pudendal block in children aged 1-7 years undergoing hypospadias surgery
Design
This study will be conducted as a randomized, double-blind (outcome evaluator and statistical analyzer), phase 3 clinical trial with parallel groups, on 80 eligible patients. The table of random numbers provided by sealedenvelope.com will be used for randomization.
Settings and conduct
This study will be conducted on eligible patients at Children's Medical Center. After receiving anesthesia, the patients will be randomly divided into one of two study groups and will receive the relevant intervention. The outcome evaluator and the statistical analyst will be unaware of the type of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA class 1 to 2 according to the American Society of Anesthesiologists; Age is between 1 to 7 years; A candidate for MRI under anesthesia.
Exclusion criteria: Presence of sensory or motor disorder in the perineum or lower limb; Having neurological and psychological disorders; History of frequent or continuous use of painkillers; Allergy to local anesthetics; Congenital or secondary coagulation disorders; Local infection at the site of injection; Anomalies of the sacrum.
Intervention groups
All patients: oral Midazolam 0.5 mg/kg, 15 minutes before entering the operating room; Anesthesia induction with inhaled Sevoflurane and 0.1 micrograms of IV Fentanyl and 0.5 mg/kg Atracurium, followed by intubation and continued anesthesia with inhaled Isoflurane
Group 1: Placing the patient in the lateral position and injecting 0.5cc/kg of 0.2% ropivacaine in the caudal epidural.
Group 2: Placing the patient in the frog position and injecting 0.5cc/kg of ropivacaine 0.2% in the pudendal nerve.
Main outcome variables
Severity of postoperative pain based on the CHEOPS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151221025641N9
Registration date:2024-05-29, 1403/03/09
Registration timing:prospective
Last update:2024-05-29, 1403/03/09
Update count:0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Parisa Kianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2660 2854
Email address
pk.pioneer1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra and postoperative analgesic effect of caudal block and ultrasound guided pudendal block in children aged 1-7 years undergoing hypospadias surgery
Public title
Comparison of intra and postoperative analgesic effect of caudal block and ultrasound guided pudendal block in children aged 1-7 years undergoing hypospadias surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is classified as ASA class 1 to 2 according to the American Society of Anesthesiologists;
The patient's age is between 1 to 7 years;
The patient is a candidate for MRI under anesthesia;
Exclusion criteria:
Presence of sensory or motor disorder in the perineum or lower limb
Having neurological and/or psychological disorders like seizures, autism or ADHD
History of frequent or continuous use of painkillers
Allergy to local anesthetics
Congenital or secondary (due to taking anticoagulants) coagulation disorders
Local infection at the site of injection
Anomalies of the sacrum
Age
From 1 year old to 7 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random number table method through blocks of 3 created by referring to www.sealedenvelope.com.
In this method, 80 eligible patients will be randomly divided into 20 blocks including 4 patients; Then, each of the 4 patients in the block will be randomly assigned to one of the 2 study groups based on the sequence provided by the site, so that 40 patients will be assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome evaluator and the statistical analyzer will be unaware of the type of intervention. A trained staff (anesthesiologist) who is not a member of the research group will evaluate the intended outcomes after the intervention is completed by the anesthesiologist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1913914435
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.TUMS.CHMC.REC.1402.164
Health conditions studied
1
Description of health condition studied
Hypospadias surgery
ICD-10 code
N50.9
ICD-10 code description
Disorder of male genital organs, unspecified
Primary outcomes
1
Description
Severity of postoperative pain based on the CHEOPS scale