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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046516
Receipt No. R000053069
Scientific Title Comparison of analgesic management in pediatric patients undergoing laparoscopic inguinal hernia surgery
Date of disclosure of the study information 2022/01/11
Last modified on 2021/12/31

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Basic information
Public title Comparison of analgesic management in pediatric patients undergoing laparoscopic inguinal hernia surgery
Acronym Analgesic management in pediatric patients undergoing laparoscopic inguinal hernia surgery
Scientific Title Comparison of analgesic management in pediatric patients undergoing laparoscopic inguinal hernia surgery
Scientific Title:Acronym Analgesic management in pediatric patients undergoing laparoscopic inguinal hernia surgery
Region
Japan

Condition
Condition Inguinal hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare rectus sheath block and epidural block regarding the postoperative analgesic effect in pediatric patients undergoing laparoscopic inguinal hernia surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The degree of postoperative pain evaluated by CHEOPS score and VAS on the day of surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epidural block (Th9-12; 0.25% levobupivacaine 0.4ml/kg) after induction of anesthesia and before the initiation of surgery
Interventions/Control_2 Both side of rectus sheath block (0.25% levobupivacaine 0.2ml/kg x 2) after induction of anesthesia and before the initiation of surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients (2~12 years old) undergoing laparoscopic inguinal hernia surgery
Key exclusion criteria Platelet count < 100000/mm3
PT-INR > 1.5
Mental retardation
Patients who are considered as inappropriate for inclusion
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Suzuki
Organization Tokai University School of Medicine
Division name Department of Anesthesiology
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193 Japan
TEL 0463-93-1121
Email takeshi-su@tsc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Suzuki
Organization Tokai University School of Medicine
Division name Department of Anesthesiology
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193 Japan
TEL 0463-93-1121
Homepage URL
Email takeshi-su@tsc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization Department of Anesthesiology, Tokai University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board for Clinical Research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193 Japan
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 17 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 12 Month 31 Day
Last modified on
2021 Year 12 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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