UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015684 |
|---|---|
| Receipt number | R000018233 |
| Scientific Title | Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial |
| Date of disclosure of the study information | 2014/11/13 |
| Last modified on | 2017/04/18 12:10:35 |
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Basic information
Public title
Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Acronym
Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Scientific Title
Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Scientific Title:Acronym
Brachial plexus block compared with periarticular injection for pain control following arthroscopic rotator cuff repair: a randomized controlled trial
Region
| Japan |
Condition
Condition
Rotator cuff tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of brachial plexus block and periarticular injection for arthroscopic rotator cuff repair
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain score (Numeric Rating Scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Brachial plexus block
Interventions/Control_2
Periarticular injection
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for arthroscopic rotator cuff repair.
Key exclusion criteria
Patients with ASA status III-V, renal insufficiency, hepatic insufficiency, blood coagulation abnormality, prolonged QT interval on electrocardiograms, respiratory complication, poor controlled DM, and allergy or intolerance to one of the study drugs.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Saito, Atsushi Tasaki, Sachiyuki Tsukada |
Organization
St. Luke's international Hospital
Division name
Orthopaedic Surgery
Zip code
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560 Japan
TEL
+81-3(3541)5151
s8058@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Saito, Atsushi Tasaki, Sachiyuki Tsukada |
Organization
St. Luke's International Hospital
Division name
Orthopaedic Surgery
Zip code
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, 104-8560 Japan
TEL
+81-3(3541)5151
Homepage URL
s8058@nms.ac.jp
Sponsor or person
Institute
St. Luke's international hospital
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 | 11 | Month | 13 | 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
| 2014 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | 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 | 11 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018233
