UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027291
Receipt No. 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 2017/05/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email mokada@med.id.yamagata-u.ac.jp

Sponsor
Institute yamagata university faculty of medicine department of anesthesiology
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 13 Day
Date of IRB
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
2017 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.