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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033279
Receipt No. R000037940
Scientific Title The comparative study of the pain management in total knee arthroplasty by intraarticular local anesthetic (mepivacaine) injection.
Date of disclosure of the study information 2018/07/04
Last modified on 2020/01/06

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Basic information
Public title The comparative study of the pain management in total knee arthroplasty by intraarticular local anesthetic (mepivacaine) injection.
Acronym Pain management in total knee arthroplasty by intraarticular local anesthetic injection.
Scientific Title The comparative study of the pain management in total knee arthroplasty by intraarticular local anesthetic (mepivacaine) injection.
Scientific Title:Acronym Pain management in total knee arthroplasty by intraarticular local anesthetic injection.
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 verify the effectiveness of the postoperative pain management using intraarticular local anesthetic injection in patients undergoing total knee arthroplasty for a randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analog Scale every day for a week and two week after the surgery
Key secondary outcomes The amount of the opioid up to 24 hours and 48 hours after the surgery
The range of motion of the knee every day for a week and two week after the surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mepivacaine 38ml one shot just after the opearation
Interventions/Control_2 saline 38ml one shot just after the opearation
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) more than 60 yo
2) osteoarthritis of the knee for the total knee arthroplasty
3) obtaining of informed consent
Key exclusion criteria 1) previous of the surgery of the hip or the ankle
2) previous osteomyelitis
3) not obtaining of informed consent
4) dementia
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Nobukazu
Middle name
Last name Okamoto
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Orthopaedic Surgery
Zip code 8608556
Address 1-1-1 Chuoku Honjo Kumamoto City Kumamoto JAPAN
TEL 096-373-5226
Email nobuoka9999@yahoo.co.jp

Public contact
Name of contact person
1st name Nobukazu
Middle name
Last name Okamoto
Organization Faculty of Life Sciences, Kumamoto University
Division name Department of Orthopaedic Surgery
Zip code 8608556
Address 1 1 1 Chuoku Honjo Kumamoto-City Kumamoto JAPAN
TEL 096-373-5226
Homepage URL
Email nobuoka9999@yahoo.co.jp

Sponsor
Institute Faculty of Life Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Faculty of Life Sciences, Kumamoto 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 Faculty of Life Sciences, Kumamoto University
Address 1-1-1, Chuoku, Honjo, Kumamoto-City, Kumamoto, 860-8556, JAPAN
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-u.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
2018 Year 07 Month 04 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 29 Day
Date of IRB
2018 Year 05 Month 29 Day
Anticipated trial start date
2018 Year 07 Month 04 Day
Last follow-up date
2019 Year 06 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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