UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multifidus cervicis plane block and modified multidus cervicis plane block; a comparative pilot study.
Title of the study (Brief title)	Multifidus cervicis plane block and modified multidus cervicis plane block; a comparative pilot study.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the analgesic efficacy of multifidus cervicis plane block and modified multifidus cervicis plane block in healthy volunteers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analgetic area
Key secondary outcomes	Duration of action

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Injection of 0.2% ropivacaine 20 ml into MC plane.
Interventions/Control_2	Injection of 0.2% ropivacaine 20 ml into modified MC plane.
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adult volunteers with ASA-PS I.
Key exclusion criteria	Subjects were excluded if they were younger than 20-yr or older than 50-yr, categorized into ASA-PS >1, had a history of allergy to local anesthetics, had a neurological disorder affecting the corresponding region, using opioids or steroids, or were pregnant.
Target sample size	10

Research contact person
Name of lead principal investigator	Yuichi Ohgoshi
Organization	International University of Health and Welfare Mita Hosipital
Division name	Department of Anesthesiology
Address	1-4-3 Mita, Minato-ku, Tokyo, 108-8329, Japan
TEL	+81-3-34518121
Email	ohgoshi22@gmail.com

Public contact
Name of contact person	Yuichi Ohgoshi
Organization	International University of Health and Welfare Mita Hosipital
Division name	Department of Anesthesiology
Address	1-4-3 Mita, Minato-ku, Tokyo, 108-8329, Japan
TEL	+81-3-34518121
Homepage URL
Email	ohgoshi22@gmail.com

Sponsor
Institute	International University of Health and Welfare Mita Hosipital
Institute
Department

Funding Source
Organization	None.
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 04 Month 28 Day
Last modified on	2018 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031149