UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005745 |
|---|---|
| Receipt number | R000005821 |
| Scientific Title | The effect of continuous Intra-articurar infusion of Ropivacaine on postoperative pain following shoulder |
| Date of disclosure of the study information | 2011/06/09 |
| Last modified on | 2015/06/08 12:20:27 |
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Basic information
Public title
The effect of continuous Intra-articurar infusion of Ropivacaine on postoperative pain following shoulder
Acronym
The effect of continuous Intra-articurar infusion of Ropivacaine on postoperative pain following shoulder
Scientific Title
The effect of continuous Intra-articurar infusion of Ropivacaine on postoperative pain following shoulder
Scientific Title:Acronym
The effect of continuous Intra-articurar infusion of Ropivacaine on postoperative pain following shoulder
Region
| Japan |
Condition
Condition
Patients required shoulder arthroscopic surgery
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpouse of this study is to determine the analgestic efficacy of subacrominal infusion of ropivacaine after shoulder arthroscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
numerical rating scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients are scheduled to receive an inter scalene brachial plexus block.
0.2%ropivacaine at 2ml/h via infusion pump into the sub acromal space.
Pain is evaluated using numerical rating scale (NRS) until 24 houres after surgery.
Interventions/Control_2
All patients are scheduled to receive an inter scalene brachial plexus block.
0.2%ropivacaine at 4ml/h via infusion pump into the sub acromal space.
Interventions/Control_3
All patients are scheduled to receive an inter scalene brachial plexus block.
0.2%ropivacaine at 8ml/h via infusion pump into the sub acromal space.
Interventions/Control_4
Patients receive an inter scalene brachial plexus block only
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing arthroscopic rotator cuff repair
Key exclusion criteria
hepatic dysfunction
renal dysfunction
obesity
reoperation
medicine allergy
ASA physical status >=3
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Kohno |
Organization
HigashiOmiya General hospital
Division name
Anestesiology
Zip code
Address
5-18 HigasiOmiya,minuma-ku,Saitama-City,Japan
TEL
0486847111
ykohno-ymi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Kohno |
Organization
HigashiOmiya General hospital
Division name
Anestesiology
Zip code
Address
5-18.HigasiOmiya,minuma-ku,Saitama-City,Japan
TEL
0486847111
Homepage URL
ykohno-ymi@umin.ac.jp
Sponsor or person
Institute
HigashiOmiya General hospital
Institute
Department
Personal name
Funding Source
Organization
HigashiOmiya General hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東大宮総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 09 | 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
Suspended
Date of protocol fixation
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | 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
| 2011 | Year | 06 | Month | 08 | Day |
Last modified on
| 2015 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005821
