UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056128 |
|---|---|
| Receipt number | R000064034 |
| Scientific Title | Evaluation of cutaneous sensory block area of the external oblique intercostal block: a prospective observational study |
| Date of disclosure of the study information | 2024/11/12 |
| Last modified on | 2024/11/12 13:06:18 |
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Basic information
Public title
Evaluation of cutaneous sensory block area of the external oblique intercostal block: a prospective observational study
Acronym
Evaluation of cutaneous sensory block area of the external oblique intercostal block: a prospective observational study
Scientific Title
Evaluation of cutaneous sensory block area of the external oblique intercostal block: a prospective observational study
Scientific Title:Acronym
Evaluation of cutaneous sensory block area of the external oblique intercostal block: a prospective observational study
Region
| Japan |
Condition
Condition
Laparoscopic upper abdominal surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the distribution of cutaneous sensory block area after the external oblique intercostal block using a pinprick test.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cutaneous Sensory Block Area (CSBA) after external oblique intercostal block
Key secondary outcomes
1. Distribution of CSBA in the thoracoabdominal wall
2. The extent of dermatomal spread following the EOI block
3. Potential applicability of the block for major upper abdominal surgery incisions
4. The relationship between CSBA and body landmarks
5. Duration of sensory blockade
6. The quality of sonographic imaging during EOI block
7. Pain-related outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 to 80 years
2. Patients scheduled for laparoscopic upper abdominal surgery
3. Patients with American Society of Anesthesiologist (ASA) physical status I-III
Key exclusion criteria
1. Allergy to the study drug
2. Body weight below 45 kg
3. Body mass index exceeding 40 kg/m2
4. History of thoracotomy or laparotomy
5. Neuropathy of the thoracoabdominal wall
6. Patients with poor capacity for consent
7. Severe hepatic or renal failure
8. Operation time exceeding 4 hours
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujino |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3813-3111
t-fujino@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujino |
Organization
Juntendo University School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3813-3111
Homepage URL
t-fujino@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo 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
Research Ethics Committee Faculty Of Medicine, Juntendo University
Address
3-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
+81-3-5802-1584
hongo-rinri@juntendo.ac.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
| 2024 | Year | 11 | Month | 12 | 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
| 2024 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Thirty subjects meeting the inclusion criteria and consenting to participate, scheduled to undergo laparoscopic upper abdominal surgery at our institution between the start of the study and December 2025.
Management information
Registered date
| 2024 | Year | 11 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064034
