UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046516 |
|---|---|
| Receipt number | 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 | 2024/01/04 09:34:53 |
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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
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
takeshi-su@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
