UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052472 |
|---|---|
| Receipt number | R000059848 |
| Scientific Title | Randomized Comparison Of Analgesic Efficacy Between Popliteal Plexus Block And iPACK Block After Total Knee Arthroplasty: A Noninferiority Study |
| Date of disclosure of the study information | 2023/10/12 |
| Last modified on | 2023/11/16 16:44:18 |
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Basic information
Public title
Randomized Comparison Of Analgesic Efficacy Between Popliteal Plexus Block And iPACK Block After Total Knee Arthroplasty: A Noninferiority Study
Acronym
Randomized Comparison Of Analgesic Efficacy Between Popliteal Plexus Block And iPACK Block After Total Knee Arthroplasty: A Noninferiority Study
Scientific Title
Randomized Comparison Of Analgesic Efficacy Between Popliteal Plexus Block And iPACK Block After Total Knee Arthroplasty: A Noninferiority Study
Scientific Title:Acronym
Randomized Comparison Of Analgesic Efficacy Between Popliteal Plexus Block And iPACK Block After Total Knee Arthroplasty: A Noninferiority Study
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to test the hypothesis that the Popliteal Plexus Block (PPB) is non-inferior to the iPACK block in terms of the incidence of posterior knee pain in patients undergoing Total Knee Arthroplasty (TKA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of moderate to severe posterior knee pain
Key secondary outcomes
Pain score
Procedure-related date
Motor and sensory assessment
Opioid consumption
Knee functional assessment
Quality of recovery
Consumption of postoperative additional analgesics
Complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Popliteal Plexus Block(PPB) with 0.25% levobupivacaine 15 mL
Interventions/Control_2
Infiltration between the popliteal artery and capsule of the knee (iPACK) block with 0.25% levobupivacaine 15 mL
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants aged between 18 and 85 years
2. Participants were scheduled for primary unilateral TKA for osteoarthritis
3. American Society of Anaesthesiologists Physical Status Classification I-III
4. Body mass index less than 40 kg/ m2
5. Written informed consent is provided
Key exclusion criteria
1. Pre-existing lower limb motor dysfunction
2. Allergy to any drug administered in this study
3. Renal failure
4. Uncontrolled asthma
5. Inability to provide informed consent
6. Contraindication for peripheral nerve block
7. Coagulopathy
Target sample size
90
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
| 2023 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059848
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| Registered date | File name |
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