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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name