UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054154 |
|---|---|
| Receipt number | R000061674 |
| Scientific Title | The change characteristics of the High Frequency Variability Index (HFVI) during ultrasound-guided peripheral nerve block in lower limb surgery |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/15 12:57:17 |
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Basic information
Public title
The change characteristics of the High Frequency Variability Index (HFVI) during ultrasound-guided peripheral nerve block in lower limb surgery
Acronym
The change characteristics of the High Frequency Variability Index (HFVI) during ultrasound-guided peripheral nerve block in lower limb surgery
Scientific Title
The change characteristics of the High Frequency Variability Index (HFVI) during ultrasound-guided peripheral nerve block in lower limb surgery
Scientific Title:Acronym
The change characteristics of the High Frequency Variability Index (HFVI) during ultrasound-guided peripheral nerve block in lower limb surgery
Region
| Japan |
Condition
Condition
patients recieving the lower limb surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate whether the High Frequency Variability Index(HFVI) can be used as an indicator of efficacy of the peripheral nerve block (PNB) by revealing the effect of effective PNB on HFVI
To investigate whether opioids can be administered based on the change characteristics of HFVI after nerve blocks, taking into account the impact of pain that cannot be treated with PNB such as Tourniquet Pain, and to verify if it can serve as an indicator for adequate opioid administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the changes of HFVI after PNB
Key secondary outcomes
Comparison of opioid administration between the group where opioid administration was guided by HFVI values and the group where opioids were administered conventionally
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing the orthopaedic lower limb surgery
Key exclusion criteria
the patients with serious cardiovascular dosease, who are American Society of Anestheologists physical status class 3 or more, who are administered an anticholinergic agent,with arrhythmia or implanted pacemaker and inappropriate recordind of HFVI.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Motoi |
| Middle name | |
| Last name | Kumagai |
Organization
Iwate medical universty hospital
Division name
Department of Anesthesiology
Zip code
020
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
0196137111
motoij@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Kumagai |
Organization
Iwate medical university hospital
Division name
Department of Anesthesiology
Zip code
028-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
0196137111
Homepage URL
motoij@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university hospital
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
Iwate medical university hospital
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
0196137111
motoij@iwate-med.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 | 04 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061674
| 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 |
