UMIN-CTR Clinical Trial

Basic information
Public title	The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Acronym	The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Scientific Title	The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Scientific Title:Acronym	The incidence of phrenic nerve palsy after Clavipectoral fascial plane block
Region	Japan

Condition
Condition	Patient with clavicle fracture
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We demonstrate that phrenic palsy has not occurred after the Clavipectoral fascial plane block.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of phrenic palsy
Key secondary outcomes

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patient with clavicle fracture
Key exclusion criteria	Patients without consent
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Yoshimura
Organization	Ube industries central hospital
Division name	Anesthesiology
Zip code	755-0151
Address	Nishikiwa570 Ube-city
TEL	0836-51-9980
Email	manabu-ygc@umin.ac.jp

Public contact
Name of contact person	1st name manabu Middle name Last name Yoshimura
Organization	Ube industries Central Hospital
Division name	Aneshtesiology
Zip code	755-0151
Address	Nishikiwa750 Ube-city
TEL	0836-51-9980
Homepage URL
Email	manabu-ygc@umin.ac.jp

Sponsor
Institute	Ube industries central Hospital
Institute
Department

Funding Source
Organization	Ube industries 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	Ube industrie central hospital
Address	Nihikiwa750 Ube-city
Tel	0836-51-9980
Email	hiromi.kato@ube-hp.or.jp

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	2020 Year 01 Month 31 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	Open public recruiting
Date of protocol fixation	2019 Year 11 Month 08 Day
Date of IRB	2019 Year 11 Month 08 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044876