Evaluation and comparison of the effect of two methods of pudendal anesthesia and dorsal penile nerve block (DPNB) on reducing pain after neonatal circumcision
Determining and comparing the mean pain score based on the neonatal infant pain scale (NIPS ) before circumcision between the two groups of pudendal and dorsal penile nerve block anesthesia
Determination and comparison of mean pain score based on NIPS neonatal infant pain scale six hours after circumcision between the two groups of pudendal and dorsal penile nerve block anesthesia
Design
The trial consists of two double-blind study groups in which the researcher and the patient are unaware of the patient's anesthesia and are randomized. Excel software rand function will be used for randomization.phase 3 with 88 patients.
Settings and conduct
After obtaining consent, patients are randomly divided into two groups: pudendal anesthesia and dorsal penile nerve block and are circumcised in the operating room of Imam Hossein Hospital. Immediately after the surgery and six hours after surgery, the amount of pain of the patient will be examined and registered. The patient and the results recorder and data analyzer will not be aware of the anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infants between 1 and 3 months who have the consent of parents to participate in the project
Exclusion criteria: People under 1 month and over 3 months; parental dissatisfaction with either circumcision or plan; children with hypospadias,
, fever, underlying disease or jaundice
Intervention groups
Children between the ages of one and three months undergoing circumcision and receiving anesthesia by the pudendal method.
Children between the ages of one and three months who undergo circumcision, and receive anesthesia by the dorsal penile nerve block method.
Main outcome variables
pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201110049338N1
Registration date:2021-02-20, 1399/12/02
Registration timing:prospective
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Ali Fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8850
Email address
alifazeli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of two methods of pudendal anesthesia and dorsal penile nerve block (DPNB) on reducing pain after neonatal circumcision
Public title
Evaluation and comparison of the effect of two methods of pudendal anesthesia and dorsal penile nerve block (DPNB) on reducing pain after neonatal circumcision
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The children should be in defined age range
They should be candidates for local anesthesia circumcision
They shouldn't have underlying disease
Exclusion criteria:
Age
From 1 month old to 3 months old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple and individuals are randomly divided into two different clusters of anesthesia after obtaining a random number and the operation will be performed according to which group each patient is in.
MATLAB R 2019 software is used.
rand i command code is used.
The person who randomizes is unaware of the type of group, which one belongs to which code
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient doesn't know how he becomes anesthetized.
The data analyzer doesn't know about the procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Scienses
Street address
Hear jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-08, 1399/07/17
Ethics committee reference number
IR.MUI.MED.REC.1399.586
Health conditions studied
1
Description of health condition studied
Reducing pain after circumcision
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain scal after circumcision
Timepoint
0 and 6 hours after circumcision
Method of measurement
neonatal infant pain scale' score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: pain scale with pudendal anesthesia method in patients who undergo circumcision with lidocaine immediately after surgery and six hours after surgery
Category
Rehabilitation
2
Description
Intervention group: pain scale with dorsal penile nerve block anesthesia method in patients who undergo circumcision with lidocaine immediately after surgery and six hours after surgery
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Mehrdad Memarzade
Street address
Imam Khomeini
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۵۱۶۳۳۸۱
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Anooshe Zargar kharrazi
Street address
Hear jarib
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.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
دکتر علی فاضلی
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2533
Email
Fazeli_fazeli2011@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Ali Fazeli
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2533
Email
Fazeli_fazeli2011@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Ali Fazeli
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2533
Email
Fazeli_fazeli2011@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Pain score of each patient after discovering patient in details
When the data will become available and for how long
3 months after publication
To whom data/document is available
Only for researches in Universities and scientific institutions.
Under which criteria data/document could be used
The person should be university faculty and jost for citation
From where data/document is obtainable
Fazeli_fazeli2011@yahoo.com
What processes are involved for a request to access data/document
After sending the request to the author's email and confirming the identity of the applicant, the documents will be sent by a week to him/her.