Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001211752
Ethics application status
Approved
Date submitted
27/07/2022
Date registered
8/09/2022
Date last updated
1/10/2023
Date data sharing statement initially provided
8/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of postoperative pain and parental satisfaction in circumcision operations.
Scientific title
Between Penile Block and Infiltrative Blocks in Circumcision Operations; Evaluation of Postoperative Pain and Parental Satisfaction.
Secondary ID [1] 307719 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
circumcision operations 327178 0
postoperative pain 327180 0
Condition category
Condition code
Anaesthesiology 324314 324314 0 0
Pain management
Surgery 324315 324315 0 0
Other surgery
Renal and Urogenital 324316 324316 0 0
Normal development and function of male and female renal and urogenital system
Neurological 324317 324317 0 0
Studies of the normal brain and nervous system
Anaesthesiology 324318 324318 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
After the participants accepted to participate in the study, the records of the operation performed with two different blocks performed by the registered surgeon will be taken. The infiltration block will be administered subcutaneously by the surgeon registered in the operation area. Penile block will be performed by administering local anesthetic around the penile nerve in order to block the dorsal nerves of the penis. Both blocks will be performed by the registered surgeon. Local anesthetic dose and type will be the same. Postoperative pain assessments will be made. Parents of the children in both groups will be given a parent satisfaction questionnaire to be completed in about half an hour just before discharge, and they will be asked to answer the questions. ECG, oxygen saturation, heart rate monitorization values will be recorded. The anesthesia procedure to be applied during the operation will be the same for each patient.
The observation period starts with the operation and ends with the discharge. Registrations will be carried out by the registered anesthetist.
Intervention code [1] 324120 0
Diagnosis / Prognosis
Comparator / control treatment
Penil block; Local anesthetic will be applied to the penis to desensitize the dorsal nerves of the penis.
Control group
Active

Outcomes
Primary outcome [1] 332120 0
Postoperative pain will be evaluated with the Visual Analog Scale (VAS), and the Face, Legs, Activity, Cry, Consolabilty(FLACC) pain scale.
Timepoint [1] 332120 0
Children will participate in postoperative 1 hour evaluations.
Secondary outcome [1] 412296 0
Parental satisfaction will be evaluated with 'Pediatric anesthesia parent satisfaction (PAPS).
Timepoint [1] 412296 0
parents will participate in the evaluation just before discharge. at approximately 6 hours postoperatively.

Eligibility
Key inclusion criteria
3-12 age
normal mental health
Minimum age
3 Years
Maximum age
12 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
mental disorder

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/08/2022
Date of last participant enrolment
Anticipated
Actual
29/06/2023
Date of last data collection
Anticipated
31/08/2023
Actual
29/06/2023
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 24920 0
Turkey
State/province [1] 24920 0
Karaman

Funding & Sponsors
Funding source category [1] 311924 0
Hospital
Name [1] 311924 0
Karaman training and research hospital
Country [1] 311924 0
Turkey
Primary sponsor type
Individual
Name
Hatice Toprak
Address
University, Karamanoglu Mehmetbey University, Yunus Emre Campus, 70200 Karaman Center/Karaman
Country
Turkey
Secondary sponsor category [1] 313485 0
None
Name [1] 313485 0
None
Address [1] 313485 0
None
Country [1] 313485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311290 0
Karamanoglu Mehmetbey Üniversity Medicine Fakulty Etihics Committee
Ethics committee address [1] 311290 0
Ethics committee country [1] 311290 0
Turkey
Date submitted for ethics approval [1] 311290 0
29/06/2022
Approval date [1] 311290 0
22/07/2022
Ethics approval number [1] 311290 0
06-2022/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120590 0
Dr Hatice Toprak
Address 120590 0
Karamanoglu Mehmetbey Üniversitesi, Yunus Emre Kampüsü, 70200 Karaman Merkez/Karaman
Country 120590 0
Turkey
Phone 120590 0
+90 05357827688
Fax 120590 0
Email 120590 0
[email protected]
Contact person for public queries
Name 120591 0
Hatice Toprak
Address 120591 0
Karamanoglu Mehmetbey Üniversitesi, Yunus Emre Kampüsü, 70200 Karaman Merkez/Karaman
Country 120591 0
Turkey
Phone 120591 0
+90 05357827688
Fax 120591 0
Email 120591 0
[email protected]
Contact person for scientific queries
Name 120592 0
Hatice Toprak
Address 120592 0
Karamanoglu Mehmetbey Üniversitesi, Yunus Emre Kampüsü, 70200 Karaman Merkez/Karaman
Country 120592 0
Turkey
Phone 120592 0
+9005357827688
Fax 120592 0
Email 120592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
none


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16841Ethical approvalKaramanoglu Mehmetbey University Faculty of Medicine Ethics Committee  



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.