UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of Quadratus Lumborum Block as a postoperative analgesia for Total Hip Arthroplasty.
Acronym	The efficacy of Quadratus Lumborum Block as a postoperative analgesia for Total Hip Arthroplasty.
Scientific Title	The efficacy of Quadratus Lumborum Block as a postoperative analgesia for Total Hip Arthroplasty.
Scientific Title:Acronym	The efficacy of Quadratus Lumborum Block as a postoperative analgesia for Total Hip Arthroplasty.
Region	Japan

Condition
Condition	Hip osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The strength maintenance of Hip joint after Quadratus Lumborum Block(QLB).
Basic objectives2	Others
Basic objectives -Others	Analgesic effect in postoperative period.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The muscle strength of hip flexion using by hand held dynamometer 6 hours after total hip arthroplasty.
Key secondary outcomes	Postoperative analgesic scores (0,6,12,24,48 hours), The muscle strength of hip flexion using by hand held dynamometer(0,12,24,48 hours), Complications. The effective are of QLB.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	QLB
Interventions/Control_2	Lumber Plexus Block(LPB)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Initial total hip arthroplasty.
Key exclusion criteria	Blood platelet disorder, Coagulation intolerance. Difficulty to have a communicate.
Target sample size	58

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Iida
Organization	Asahikawa Medical University
Division name	Anesthesiology and Critical Care Medicine
Zip code	0788510
Address	Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL	0166682583
Email	takka1845@fg7.so-net.ne.jp

Public contact
Name of contact person	1st name Takafumi Middle name Last name Iida
Organization	Asahikawa Medical University
Division name	Anesthesiology and Critical Care Medicine
Zip code	0788510
Address	Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
TEL	0166682583
Homepage URL
Email	takka1845@fg7.so-net.ne.jp

Sponsor
Institute	Asahikawa medical university
Institute
Department

Funding Source
Organization	Department of Anesthesiology and critical care medicine ,Asahikawa medical university
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	Asahikawa Medical University
Address	Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
Tel	0166682583
Email	pikaseika@jimu.asahikawa-med.ac.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	2017 Year 11 Month 14 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	Terminated
Date of protocol fixation	2017 Year 09 Month 22 Day
Date of IRB	2017 Year 11 Month 10 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2021 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	2017 Year 11 Month 10 Day
Last modified on	2021 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034171