UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060438 |
|---|---|
| Receipt number | R000069139 |
| Scientific Title | Effects of different peripheral nerve block techniques on postoperative pain and motor function after total knee arthroplasty |
| Date of disclosure of the study information | 2026/01/26 |
| Last modified on | 2026/01/22 12:23:16 |
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Basic information
Public title
A study investigating how different pain relief methods after total knee replacement surgery affect pain and ease of movement
Acronym
A study on pain relief methods and recovery after knee surgery
Scientific Title
Effects of different peripheral nerve block techniques on postoperative pain and motor function after total knee arthroplasty
Scientific Title:Acronym
PNB-TKA Study
Region
| Japan |
Condition
Condition
Osteoarthritis of the Knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the analgesic effects and impact on postoperative functional recovery during the perioperative period of bilateral simultaneous total knee arthroplasty in patients with knee osteoarthritis, by administering a continuous femoral nerve block on one side and a continuous adductor canal block on the opposite side.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are pain, number of additional analgesic doses administered, quadriceps strength measured using the Q-setting, date of first successful active leg raise, and date of first successful single-leg stance with upper limb support. Pain and quadriceps strength using the Q-setting will be assessed on postoperative days 1, 3, 5, and 7.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients undergoing bilateral total knee arthroplasty were randomly assigned to either a continuous femoral nerve block group or a continuous adductor canal block group.
Interventions/Control_2
Begin continuous infusion of 0.25% popradocain at 3 ml/h postoperatively. Remove the catheter for continuous peripheral nerve block on the second postoperative day.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing bilateral simultaneous total knee arthroplasty for bilateral osteoarthritis of the knee.
Key exclusion criteria
Patients with rheumatoid arthritis, patients with a history of neuromuscular disease, patients whose preoperative walking ability requires a wheelchair.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Kubo |
Organization
Fukui General Hospital
Division name
Department of Rehabilitation
Zip code
910-8561
Address
58-16-1 Egami, Fukui City, Fukui, Japan
TEL
0776-59-1300
fsmsc@f-gh.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Kubo |
Organization
Fukui General Hospital
Division name
Department of Rehabilitation
Zip code
910-8561
Address
58-16-1 Egami, Fukui City, Fukui, Japan
TEL
0776-59-1300
Homepage URL
fsmsc@f-gh.jp
Sponsor or person
Institute
Fukui General Hospital
Institute
Department
Personal name
Funding Source
Organization
This study received no specific funding.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nittazuka Medical Welfare Center Ethics Committee
Address
58-16-1 Egami, Fukui City, Fukui, Japan
Tel
0776-59-1300
hisyo-fgh@f-gh.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
| 2026 | Year | 01 | Month | 26 | 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
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 01 | Month | 22 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069139
