UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014001 |
|---|---|
| Receipt number | R000016192 |
| Scientific Title | A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2014/05/25 |
| Last modified on | 2017/12/02 12:19:39 |
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Basic information
Public title
A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Acronym
A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Scientific Title
A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Scientific Title:Acronym
A randomized controlled trial compairing femoral nerve block and periarticular multimodal drug injection for anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the femoral nerve block and periarticular multimodal drug injection for pain after anterior cruciate ligament reconstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative visual analog scale score at rest 24 hours after surgery.
Key secondary outcomes
Post operative visual analog scale score at rest until 14 days after surgery.
The postoperative VAS scores for patient satisfaction with pain management until 3 days after surgery.
The total amount of opioid consumption after surgery.
Post operative complication.
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 | Maneuver |
Interventions/Control_1
A femoral nerve block for pain after anterior cruciate ligament reconstruction
Interventions/Control_2
A periarticular multimodal drug injection for pain after anterior cruciate ligament reconstruction
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
| 13 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients were scheduled for primary ACL reconstruction with hamstring autograft, over 13 years old and had the ability to cooperate with data acquisition.
Key exclusion criteria
The exclusion criteria were revision ACL reconstruction, ACL reconstruction with bone-patellar tendon-bone graft, combined with other ligament reconstruction, combined with high tibial osteotomy, allergy to one of the study drugs, regular narcotic use, renal insufficiency, severe obesity (BMI > 35) and ECG abnormalities at rest.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yoshiya |
Organization
Hyogo College of Medicine
Division name
Orthopaedic surgery
Zip code
Address
663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6111
yoshiya@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Nakayama |
Organization
Hyogo College of Medicine
Division name
Orthopaedic surgery
Zip code
Address
663-8501 1-1 Mukogawa-cho, Nishinomiya City, Hyogo, Japan
TEL
0798-45-6111
Homepage URL
hiroshi0273@mac.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.arthroscopyjournal.org/article/S0749-8063(17)31173-8/pdf
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 10 | 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
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2017 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016192
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
