UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035443 |
|---|---|
| Receipt number | R000040372 |
| Scientific Title | Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty. |
| Date of disclosure of the study information | 2020/01/04 |
| Last modified on | 2020/07/06 10:38:18 |
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Basic information
Public title
Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Acronym
Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.
Scientific Title
Evaluation of the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block in patients undergoing shoulder arthroplasty.
Scientific Title:Acronym
Evaluation of the analgesic efficacy of intra-operative nerve block in patients undergoing shoulder arthroplasty.
Region
| Japan |
Condition
Condition
Patient who undergoing shoulder arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To Compare the analgesic efficacy of intra-operative suprascapular nerve block and axillary nerve block with interscalene block in patients who undergoing shoulder arthroplasty.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-operative pain(Visual analog scale, Numerical rating scale)
Key secondary outcomes
Duration of anesthesia, the use of rescue analgesia, the frequency of nausea and vomiting, the presence of respiratory distress, the presence of paresthesia, other nerve block complication, post-operative shoulder flexion angle, evaluation of strength of elbow flexion and extension using Manual Muscle Testing (MMT), grip strength.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Supurascapular nerve block and axillary nerve block
Interventions/Control_2
Interscalene block
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing primary hemiarthroplasty, total shoulder arthroplasty, reverse total shoulder arthroplasty.
Key exclusion criteria
The case where no preoperative consent is obtained.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yasuhara |
| Middle name | |
| Last name | Arashiro |
Organization
Fukuoka University Faculty of Medicine
Division name
Dept.of Orthop.Surg
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
md180001@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhara |
| Middle name | |
| Last name | Arashiro |
Organization
Fukuoka University Faculty of Medicine
Division name
Dept.of Orthop.Surg
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL
092-801-1011
Homepage URL
md180001@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukuoka University
Address
7-45-1 Nanakuma Jonan-ku, Fukuoka-shi, Fukuoka-ken
Tel
0928011011
fumed-ethics@fukuoka-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
| 2020 | Year | 01 | 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
4
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
| 2019 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040372
