UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluated the position of catheter orifice and spread of drug by using Carbon dioxide contrast-enhanced ultrasonography
Title of the study (Brief title)	Evaluated the position of catheter orifice by using Carbon dioxide contrast-enhanced ultrasonography
Region	Japan

Condition
Condition	Rotator Cuff Tear Impingement syndrome Frozen shoulder Osteoarthritis of the shoulder Reccurent Dislocated shoulder fracture of shoulder
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we attempted to evaluate the actual distance between catheter orifice and C5/C6 nerve roots by using carbon dioxide (CO2) contrast-enhanced ultrasonography technique.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We measured the distance between catheter orifice and C5/C6 nerve by CO2 contrast-enhanced ultrasonography technique in the recovery room and at 24 hours after the operation. Concurrently, patients were examined VAS score, decrease in perception of C5/C6 nerve area and manual muscle test (MMT) of biceps. We also examined the correlation between these distances and clinical scores.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment Maneuver
Interventions/Control_1	0.75 % ropivacaine 15ml was administered preoperatively via the catheter before surgery under general anesthesia. A ropivacaine 0.25% 4 ml/hour infusion with mandatory 24 hours, and on-demand half an hourly, 3 ml boluses was allowed as rescure.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing a shoulder joint surgery, obtained the consent
Key exclusion criteria	Patients with oral anti-platelet drugs
Target sample size	30

Research contact person
Name of lead principal investigator	Hayato Shimizu
Organization	Nagayoshi General Hospital
Division name	Orthopedics
Address	Osaka city Hirano Nagayoshinagahara 1- 2-34
TEL	06-6709-0301
Email	hyt_1jd@yahoo.co.jp

Public contact
Name of contact person	Hayato Shimizu
Organization	Nagayoshi General Hospital
Division name	Orthopedics
Address	Osaka city Hirano Nagayoshinagahara 1- 2-34
TEL	06-6709-0301
Homepage URL
Email	hyt_1jd@yahoo.co.jp

Sponsor
Institute	Nagayoshi General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	no
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	2016 Year 06 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 18 Day
Anticipated trial start date	2016 Year 06 Month 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 11 Day
Last modified on	2016 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026138