UMIN-CTR Clinical Trial

Basic information
Public title	Lateral cutaneous branch block and total abdominal wall block procedure: a volunteer study
Acronym	Lateral cutaneous branch block and total abdominal wall block procedure: a volunteer study
Scientific Title	Lateral cutaneous branch block and total abdominal wall block procedure: a volunteer study
Scientific Title:Acronym	Lateral cutaneous branch block and total abdominal wall block procedure: a volunteer 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 TAPA and TAP blocks and lateral cutaneous branch block in healthy volunteers, to develop total abdominal anesthesia.
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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Injection of 0.2% ropivacaine 20 ml (in total 40 ml) into TAPA, M-TAPA, or TAP plane, and 20 ml into LCB plane.
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	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	8

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Ohgoshi
Organization	Keiyu Hospital
Division name	Department of Anesthesiology
Zip code	220-8521
Address	3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
TEL	+81-45-2218181
Email	ohgoshi22@gmail.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Ohgoshi
Organization	Keiyu Hospital
Division name	Department of Anesthesiology
Zip code	220-8521
Address	3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
TEL	+81-45-2218181
Homepage URL
Email	ohgoshi22@gmail.com

Sponsor
Institute	Keiyu Hospital
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)

IRB Contact (For public release)
Organization	Keiyu Hospital
Address	3-7-3 Minatomirai, Nishi-ku, Yokohama, Kanagawa, 220-8521, Japan
Tel	0452218181
Email	ohgoshi22@gmail.com

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	2021 Year 12 Month 12 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	18
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	Completed
Date of protocol fixation	2021 Year 12 Month 01 Day
Date of IRB	2021 Year 12 Month 15 Day
Anticipated trial start date	2021 Year 12 Month 15 Day
Last follow-up date	2022 Year 01 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	2021 Year 11 Month 29 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052741