UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026417
Receipt number R000030346
Scientific Title Perineural dexmedetomidine prolong the duration of analgesia: RCT
Date of disclosure of the study information 2017/03/06
Last modified on 2021/04/19 09:15:12

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Basic information

Public title

Perineural dexmedetomidine prolong the duration of analgesia: RCT

Acronym

DEX adjuvant local alagesic: RCT

Scientific Title

Perineural dexmedetomidine prolong the duration of analgesia: RCT

Scientific Title:Acronym

DEX adjuvant local alagesic: RCT

Region

Japan


Condition

Condition

the patients received trunk block

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to confirm that addition of dexmedetomidine will prolong the duration of analgesia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

first report of postoperative pain at the surgical site

Key secondary outcomes

opioid comsumption, VAS, QOR-40,


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

0.3% levobupivacaine+dexmedetomidine 1micro g/kg

Interventions/Control_2

0.3% levobupivacaine+NS

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

20-75 year old patients

Key exclusion criteria

patients intaking coagulation drug

severe disease patietns

patients we determine as unsuitability

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabu Yoshimura

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan.

TEL

0834-28-4411

Email

manabu-ygc@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manbabu Yoshimura

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-1 Kodacho, Shunan, Yamaguchi 745-8522, Japan.

TEL

0834-28-4411

Homepage URL


Email

manabu-ygc@umin.ac.jp


Sponsor or person

Institute

Japan Community Healthcare Organization Tokuyama Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Community Healthcare Organization Tokuyama Central Hospital

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

2017 Year 03 Month 06 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 06 Day

Date of IRB

2018 Year 03 Month 31 Day

Anticipated trial start date

2017 Year 03 Month 06 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 03 Month 06 Day

Last modified on

2021 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030346


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name