UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034559 |
|---|---|
| Receipt number | R000039400 |
| Scientific Title | Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2023/04/22 09:11:54 |
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Basic information
Public title
Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial
Acronym
Comparison of selective tibial nerve block and IPACK block
Scientific Title
Comparison of selective tibial nerve block and IPACK block after total knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
Comparison of selective tibial nerve block and IPACK block
Region
| Japan |
Condition
Condition
Total knee arthroplasty
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the analgesic efficacy of selective tibial nerve block and IPACK block in patients undergoing TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. VAS score
2. Range of movoment
3. Rescue consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are 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
Selective tibial nerve block 0.375% ropivacaine 5mL
Interventions/Control_2
IPACK block 0.375% ropivacaine 20mL
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Ostoarthritis of unilateral knee.
2. The patients who agreed the informed consent of participation in this study.
Key exclusion criteria
Subjects were excluded if they were younger than 40-yr or older than 90-yr, had a history of allergy to local anesthetics, had a neurological disorder affecting the corresponding region, using opioids or steroids.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ohgoshi |
Organization
Keiyu Hospital
Division name
Department of Anesthesiology
Zip code
220-8521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan
TEL
045-221-8181
ohgoshi22@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ohgoshi |
Organization
Keiyu Hospital
Division name
Department of Anesthesiology
Zip code
220-8521
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan
TEL
045-221-8181
Homepage URL
ohgoshi22@gmail.com
Sponsor or person
Institute
Keiyu Hospital
Institute
Department
Personal name
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
Keiyu Hospital
Address
3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan
Tel
045-221-8181
ohgoshi22@gmail.com
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
| 2018 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039400
