UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033279 |
|---|---|
| Receipt number | 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 | 2021/07/08 14:46:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
nobuoka9999@yahoo.co.jp
Sponsor or person
Institute
Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000037940
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000037940
Number of participants that the trial has enrolled
30
Results
The drainage volume 24 hours after the operation wewe not different between the two groups.
The VAS score 24 hours after the operation was 4.13 and 4.07 between the carbokine-administered group and the non-administered group, and no significant difference was observed between the two groups. The VAS scores at week 1 were 2 and 1.4 between the carbokine-treated group and the non-treated group, and there was no significant difference between the two groups.
Results date posted
| 2021 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 30 patients who underwent total knee arthroplasty at our hospital from July 2018 to May 2019 were included.
Participant flow
After giving an overview of the study before surgery and obtaining consent to participate in the study, surgery was performed.
Adverse events
None
Outcome measures
Drain drainage volume up to 48 hours after surgery
Knee range of motion up to 1 week after surgery
VAS score up to 1 week after surgery.
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
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.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 |
