UMIN-CTR Clinical Trial

Basic information
Public title	Is continuous transmuscular quadrates lumborum (QLB) block an effective perioperative analgesia for total hip arthroplasty?
Acronym	An efficacy of continuous transmuscular QLB block for THA.
Scientific Title	Is continuous transmuscular quadrates lumborum (QLB) block an effective perioperative analgesia for total hip arthroplasty?
Scientific Title:Acronym	An efficacy of continuous transmuscular QLB block for THA.
Region	Japan

Condition
Condition	Total hip arthroplasty.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	An efficacy of perioperative pain management for transmusucular QLB
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the cumulative fentanyl (rescue analgesia) consumption during the first 48 hours post-surgery
Key secondary outcomes	1.the number of demanded and delivered fentanyl boluses 2. the number of patients with complications such as nausea and vomiting during the first 48 hours after surgery 3. sensory level by cold tests at awake situation

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) 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	Transmuscular QLB group
Interventions/Control_2	Lumbar plexus nerve block group
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	the patients planned a total hip arthroplasty
Key exclusion criteria	secondary surgery Bilateral THA
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Ueshima
Organization	Showa University Hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8575
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)

IRB Contact (For public release)
Organization	Showa university hospital
Address	1-5-8, hatanodai, ota-ku
Tel	03-3784-8575
Email	ueshimhi@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	2016 Year 04 Month 13 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	72
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	Completed
Date of protocol fixation	2016 Year 04 Month 13 Day
Date of IRB	2016 Year 04 Month 13 Day
Anticipated trial start date	2016 Year 04 Month 13 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	2016 Year 04 Month 12 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025237