UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024853 |
|---|---|
| Receipt number | R000028603 |
| Scientific Title | Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery |
| Date of disclosure of the study information | 2016/11/16 |
| Last modified on | 2017/05/29 11:50:54 |
* 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
Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Acronym
Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Scientific Title
Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Scientific Title:Acronym
Dexamethasone as adjunct to local anesthetic in brachial plexus nerve block for shoulder surgery
Region
| Japan |
Condition
Condition
Surgical patients received arthroscopic rotator cuff repair
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to determine effect of dexamethasone in brachial plexus nerve block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analgesic duration after brachial plexus block
Key secondary outcomes
Numbers of additional analgesic after surgery; Duration of numbness after brachial plexus block
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Surgical patients received arthroscopic rotator cuff repair
Key exclusion criteria
None
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Sugino |
Organization
Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL
0227177321
sugino@ruby.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Iwakawa |
Organization
Tohoku Rosai Hospital
Division name
Department of Anesthesia
Zip code
Address
3-21, Dainohara 4, Aoba-ku, Sendai, Miyagi 981-8563, Japan
TEL
0222751111
Homepage URL
to48mutsu@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2016 | Year | 11 | Month | 16 | 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
The present results showed that addition of dexamethsone to local anesthetics was significant factor for a relief of postsurgical shoulder pain. This effect of dexamethsone produced 5 hours longer duration of analgesia.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 04 | Day |
Other
Other related information
We analyzed 112 patients in the current study.
Management information
Registered date
| 2016 | Year | 11 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028603
