UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054638 |
|---|---|
| Receipt number | R000062439 |
| Scientific Title | Comparison of Multimodal Cocktail Periarticular Injection and Peripheral Nerve Block in Pain Relief After Osteotomy Around the Knee: A Prospective Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/06/13 |
| Last modified on | 2025/06/12 22:46:03 |
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Basic information
Public title
Comparison of Multimodal Cocktail Periarticular Injection and Peripheral Nerve Block in Pain Relief After Osteotomy Around the Knee: A Prospective Randomized Controlled Trial
Acronym
Comparison of Multimodal Cocktail Periarticular Injection and Peripheral Nerve Block in Pain Relief After Osteotomy Around the Knee: A Prospective Randomized Controlled Trial
Scientific Title
Comparison of Multimodal Cocktail Periarticular Injection and Peripheral Nerve Block in Pain Relief After Osteotomy Around the Knee: A Prospective Randomized Controlled Trial
Scientific Title:Acronym
Comparison of Multimodal Cocktail Periarticular Injection and Peripheral Nerve Block in Pain Relief After Osteotomy Around the Knee: A Prospective Randomized Controlled Trial
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare the postoperative analgesic efficacy of perioperative multimodal cocktail periarticular injection and peripheral nerve block in perioperative osteotomy around the knee
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale for postoperative pain at rest measured at 4, 8, 16, and 24 hours after surgery.
Key secondary outcomes
Complication
Visual Analogue Scale during activity (measured at one to five days after surgery)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Percutaneous periarticular analgesic injection including ropivacaine 0.75% 40 mL, ketoprofen 2.5 mL [50 mg], and methylprednisolone sodium succinate 0.8 mL [50 mg] just before osteotomy around the knee.
Interventions/Control_2
A total of 20 mL of 5 mg/mL of ropivacaine was injected around the sciatic nerve and a total of 15 mL of 3.3 mg/mL of ropivacaine was injected around the femoral nerve just before
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing osteotomy around the knee for knee osteoarthritis in our hospital.
Key exclusion criteria
not meeting inclusion criteria
poorly controlled diabetes mellitus
declined to participate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Nakao |
Organization
Hyogo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo,Japan
TEL
0798-45-6452
yo-nakao@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Nakao |
Organization
Hyogo Medical University
Division name
Department of Orthopaedic Surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo,Japan
TEL
0798-45-6452
Homepage URL
yo-nakao@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical University
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
Nishinomiya institutional review board
Address
4-1, Ohama-cho, Nishinomiya, Hyogo, Japan
Tel
+81-798-33-0601
kunimi.yuuki@hmw.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
| 2024 | Year | 06 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062439
