UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027659 |
|---|---|
| Receipt number | R000031677 |
| Scientific Title | The efficacy of obturator nerve block in pain management of total knee arthroplasty |
| Date of disclosure of the study information | 2017/06/06 |
| Last modified on | 2018/09/14 17:06:57 |
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Basic information
Public title
The efficacy of obturator nerve block in pain management of total knee arthroplasty
Acronym
The efficacy of obturator nerve block in pain management of total knee arthroplasty
Scientific Title
The efficacy of obturator nerve block in pain management of total knee arthroplasty
Scientific Title:Acronym
The efficacy of obturator nerve block in pain management of total knee arthroplasty
Region
| Japan |
Condition
Condition
gonarthrosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of analgesia of an obturator nerve block added to the femoral block in total knee arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analgesia of tourniquet pain and postoperative pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
We performed one type of peripheral nerve block,femoral nerve block (0.25% levobupivacaine 20ml, containing dexamethasone 3.3mg) alone before the surgery of total knee arthroplasty. And we provided a continuous femoral nerve block catheter (0.1% levobupivacaine 4 ml/h) for postoperative analgesia.
Interventions/Control_2
We performed two types of peripheral nerve block, femoral nerve block (0.25% levobupivacaine 20 ml, containing dexamethasone 3.3mg) and obturator nerve block (0.25% levobupivacaine 20 ml, containing dexamethasone 3.3mg) before the surgery of total knee arthroplasty.And we provided a continuous femoral nerve block catheter (0.1% levobupivacaine 4 ml/h) for postoperative analgesia.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who underwent total knee arthroplasty in general anesthesia and agreed with peripheral nerve block
Key exclusion criteria
ASA physical status>3
BMI>35
allergy to local anesthetic
contraindications to regional anesthesia
preexisting neurological deficits in the lower extremities
inability to comprehend pain scales
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kataoka Asako |
Organization
Otsu City Hospital
Division name
Anesthesiology
Zip code
Address
Motomiya2-9-9,Otsu,Shiga
TEL
077-522-4607
asakomatsuda724@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kataoka Asako |
Organization
Otsu City Hospital
Division name
Anesthesiology
Zip code
Address
Motomiya2-9-9,Otsu,Shiga
TEL
077-522-4607
Homepage URL
asakomatsuda724@gmail.com
Sponsor or person
Institute
Otsu City Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
| 2017 | Year | 06 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031677
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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