UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of Programmed Intermittent Bolus of Lumbar Plexus Block for Total Hip Arthroplasty
Title of the study (Brief title)	Investigation of PIB of LPB for THA
Region	Japan

Condition
Condition	Total Hip Arthroplasty
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of effective analgesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of pushed PCEA The amount of fentanyl
Key secondary outcomes	Number of requested PCEA Number of patients used additional analgesi

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	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The set flow rate was continuous 6mL of levobupivacaine 0.1% every hour and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
Interventions/Control_2	The set flow rate was intermittent bolus of 12mL of levobupivacaine 0.1% every 2 hours and 6mL levobupivacaine 0.1% lock out time: 60 minutes for 2 days.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who schedule THA
Key exclusion criteria	secondary surgery bilateral THA
Target sample size	40

Research contact person
Name of lead principal investigator	Hironobu Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL	0337848575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	Hironobu Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan
TEL	0337848575
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Showa University Hospital
Institute
Department

Funding Source
Organization	Showa University Hospital
Organization
Division
Category of Funding Organization	Other
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 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 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	2017 Year 01 Month 20 Day
Last modified on	2018 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029646