UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051751 |
|---|---|
| Receipt number | R000059064 |
| Scientific Title | Comparison of clinical outcomes between nerve block and epidural anesthesia in laparoscopic liver resection |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/07/29 20:11:54 |
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Basic information
Public title
Comparison of clinical outcomes between nerve block and epidural anesthesia in laparoscopic liver resection
Acronym
Comparison of clinical outcomes between nerve block and epidural anesthesia in laparoscopic liver resection
Scientific Title
Comparison of clinical outcomes between nerve block and epidural anesthesia in laparoscopic liver resection
Scientific Title:Acronym
Comparison of clinical outcomes between nerve block and epidural anesthesia in laparoscopic liver resection
Region
| Japan |
Condition
Condition
liver cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will prospectively collect and compare the clinical outcomes of nerve block or epidural anesthesia as analgesia for laparoscopic hepatectomy, and investigate the usefulness of each analgesic method. We will also collect perioperative parameters to obtain basic data that will lead to more appropriate and safer anesthesia management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in pain intensity for each analgesic method on postoperative days 0-2
Key secondary outcomes
Difference in postoperative hospital stay by analgesic method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Nerve block is performed as an analgesic method in laparoscopic hepatectomy
Interventions/Control_2
Epidural anesthesia is performed as an analgesic method in laparoscopic hepatectomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older undergoing laparoscopic liver resection
Key exclusion criteria
Inability to consent, attempted manual assistance or laparotomy, second or subsequent hepatectomy, emergency surgery, conditions unsuitable for epidural anesthesia (abnormal hemostasis or coagulation, local infection, increased cerebral pressure, extreme dehydration, history of spinal surgery, spinal metastasis of malignancy, pre-existing neurologic deficit, patient refusal), allergy to regional anesthesia, preoperative narcotic use, BMI >35, renal dysfunction, presence of coronary artery disease, arrhythmia, ASA Grading III, IV, V, Child-Pugh C, tumor involvement of inferior vena cava or portal vein, central venous port placement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Shindoh |
Organization
Toranomon Hospital
Division name
Department of Digestive Surgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
0335881111(ext.7283)
shindou-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Miyanishi |
Organization
Toranomon Hospital
Division name
Department of Anesthesiology
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo
TEL
0335881111(ext.7018)
Homepage URL
mmiyanishi2023@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Shindoh Junichi
Funding Source
Organization
none
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
Toranomon Hospital
Address
2-2-2 Toranomon, Minato-ku, Tokyo
Tel
03-3588-1111(ext.3400)
chikenjimukyoku@toranomon.gr.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
| 2023 | Year | 08 | Month | 01 | 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
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059064
| Research Plan | |
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| 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 |
