UMIN-CTR Clinical Trial

Basic information
Public title	Continuous infusion of low-dose remifentanil for palliation of pain with Brachial plexus nerve block
Acronym	Remifentanil for palliation of pain with Brachial plexus nerve block
Scientific Title	Continuous infusion of low-dose remifentanil for palliation of pain with Brachial plexus nerve block
Scientific Title:Acronym	Remifentanil for palliation of pain with Brachial plexus nerve block
Region	Japan

Condition
Condition	humerus fracture forearm fracture clavicle fracture shoulder periarthritis rotator cuff tear
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	prospectively determine the safety and effectiveness of continuous infusion of low-dose remifentanil for the reduction of pain for patients with brachial plexus nerve block
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual analog scale (VAS) scores for pain after brachial plexus nerve block
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
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	none of remifentanil
Interventions/Control_2	0.02microgram/kg/min of remifentanil
Interventions/Control_3	0.05microgram/kg/min of remifentanil
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	12 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients having elective orthopedic surgery who required general anesthesia and interscalene brachial plexus block.
Key exclusion criteria	patients who can not obtain understanding of this study. patients with allergy to remifentanilor other local anesthetic.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Nana Middle name Last name Mine
Organization	Saiseikai Futsukaichi Hospital
Division name	Department of Anesthesiology
Zip code	840-0021
Address	7-26-18 Onimaru, Saga city, Saga 840-0021, Japan
TEL	090-9568-0592
Email	nanakikukawa@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Maeda
Organization	Saiseikai Futsukaichi Hospital
Division name	Department of Anesthesiology
Zip code	840-0202
Address	4103 Kutii, Yamato-town, Saga city, Saga 840-0202, Japan
TEL	09053894872
Homepage URL
Email	maeyan0222@yahoo.co.jp

Sponsor
Institute	Saiseikai Futsukaichi Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saiseikai Futsukaichi Hospital
Address	3-13-1 Yu-machi, Chikushino city, Fukuoka 818-8516, Japan
Tel	092-923-1551
Email	maeyan0222@yahoo.co.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	2019 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
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	Main results already published
Date of protocol fixation	2018 Year 06 Month 28 Day
Date of IRB	2019 Year 05 Month 21 Day
Anticipated trial start date	2018 Year 06 Month 28 Day
Last follow-up date	2020 Year 03 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	2019 Year 12 Month 26 Day
Last modified on	2019 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037610