UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	efficacy of low-dose ketamine intravenous injection under nerve root block
Title of the study (Brief title)	efficacy of low-dose ketamine intravenous injection under nerve root block
Region	Japan

Condition
Condition	neuropathic pain
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	efficacy of low-dose ketamine intravenous injection for neuropathic pain
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain score(visual analogue scale) Hospital Anxiety and Depression Scale PDAS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ketamine0.1mg/kg+saline100ml iv
Interventions/Control_2	ketamine0.3mg/kg+saline100ml iv
Interventions/Control_3	saline 100ml iv
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	Patients to plan nerve root block
Key exclusion criteria	Alcoholism Patients concurrently treated with beta-blocker Patients with a history of allergy to ketamine
Target sample size	60

Research contact person
Name of lead principal investigator	Toshiaki Minami
Organization	Osaka medical college
Division name	Department of anesthesiology
Address	2-7 daigaku-machi Takatsuki-city Osaka Japan
TEL	072-683-1221
Email	ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person	Akira Hyoda
Organization	Osaka medical college
Division name	Department of anesthesiology
Address	2-7 daigaku-machi Takatsuki-city Osaka Japan
TEL	072-683-1221
Homepage URL
Email	a-hyoda@qg7.so-net.ne.jp

Sponsor
Institute	Osaka medical college
Institute
Department

Funding Source
Organization	Osaka medical college Department of anesthesiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪医科大学付属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 05 Day
Last follow-up date	2018 Year 12 Month 27 Day
Date of closure to data entry	2019 Year 01 Month 11 Day
Date trial data considered complete	2019 Year 01 Month 18 Day
Date analysis concluded	2019 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 14 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021191