UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027291 |
|---|---|
| Receipt number | R000031249 |
| Scientific Title | The efficacy of the concomitant use of continuous interscalene block and suprascapular nerve block for pain relief after arthroscopic rotator cuff repair |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2020/05/15 20:31:18 |
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Basic information
Public title
The efficacy of the concomitant use of continuous interscalene block and suprascapular nerve block for pain relief after arthroscopic rotator cuff repair
Acronym
Continuous interscalene block with suprascapular nerve block for pain relief after arthroscopic rotator cuff repair
Scientific Title
The efficacy of the concomitant use of continuous interscalene block and suprascapular nerve block for pain relief after arthroscopic rotator cuff repair
Scientific Title:Acronym
Continuous interscalene block with suprascapular nerve block for pain relief after arthroscopic rotator cuff repair
Region
| Japan |
Condition
Condition
rotator cuff tear
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An examination for the efficacy of concomitant use of continuous interscalene block and suprascapular nerve block for pain relief after arthroscopic rotator cuff repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours after the operation: Numerical Rating Scale (0-10), Verbal Rating Scale (0-3)
Key secondary outcomes
The amount of additional analgesics, complications and adverse effects during 48 hours after the operation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The all patients undergo general anesthesia by propofol and remifentanil for the surgery and continuous interscalene block (after ultrasound-guided catheter insertion, 0.2% ropivacaine is administrated at 6ml/hour after bolus 10ml infusion) for postoperative pain relief. In addition, the patients undergo ultrasound-guided suprascapular nerve block by 10ml of 0.75% ropivacaine at the end of surgery.
Interventions/Control_2
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
The adult patients (20 years of age or older) who were scheduled to undergo arthroscopic rotator cuff repair at yamagata university hospital
Key exclusion criteria
When we did not obtain written informed consent, we failed the continuous interscalene block or the suprascapular nerve block, a patient had a contraindication of the nerve blocks, a patient could not perform self-evaluation or communicate with us such as a mental illness, or a patient had a severe underlying condition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Okada |
Organization
yamagata university faculty of medicine
Division name
department of anesthesiology
Zip code
Address
2-2-2 iidanishi, yamagata
TEL
023-628-5400
mokada@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Okada |
Organization
yamagata university faculty of medicine
Division name
department of anesthesiology
Zip code
Address
2-2-2 iidanishi, yamagata
TEL
023-628-5400
Homepage URL
http://www.anesth-yamagata-u.com
mokada@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
yamagata university faculty of medicine department of anesthesiology
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
山形大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 10 | 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 | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 05 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031249
