UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Acronym	The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Scientific Title	The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Scientific Title:Acronym	The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to elucidate the efficacy of the Quadratus Lumborum BLock for the postoperative recovery after Total Hip Arthroplasty.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quality of Recovery 40 score 24 hours after surgery.
Key secondary outcomes	1)Fentanyl consumption until 24 hours after surgery, 2)Number of times of use IV-PCA, 3)Pain at rest and effort on postoperative day1, 2(VAS), 4)Post operative nausea and vomit, 5)Intraoperative consumption of fentanyl, 6)Duration of first use of PCA, 7)Intraoperative consumption of remifentanil, 8)The frequency and dose of other analgesic requirements(i.e, flurbiprofen axetil of diclofenac), 9)The time of first ambulation, 10)The manual muscle test (MMT) results for the quadriceps muscle during day 1 of postoperative rehabilitation, 11)Perioperative complications related to surgical or anesthetic procedures (i.e, wound infection, bleeding, dislocation, reoperation, nerve injury, hypotension, or falling), 12)Days in hospital

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Injecting 0.25% levobupivacaine 30ml under ultrasound-guided Quadratus Lumborum Block anterior approach.
Interventions/Control_2	Injecting normal saline under ultrasound-guided Quadratus Lumborum Block anterior approach.
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	(1)Age over 20 years. (2)Scheduled to unilateral total hip arthroplasty. (3)ASA-PS1-2 (4)Written informed consent of this study.
Key exclusion criteria	(1)Revision cases. (2)Dysfunction of liver and kidney. (3)Coagulopathy. (4)BMI>35 (5)Strong opioid user such as morphine or fentanyl (6)Allergies to study drugs and their components (7)Dementia. (8)Cases judged to inappropriate by the researchers. For instance, cases where the patient has undergone other femoral surgeries such as intramedullary nailing.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Masaru Middle name Last name Kikuchi
Organization	Yokohama City University hospital
Division name	Anesthesiology
Zip code	236-0004
Address	236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2918
Email	kikutyqdo1009@gmail.com

Public contact
Name of contact person	1st name Masaru Middle name Last name Kikuchi
Organization	Yokohama City University hospital
Division name	Anesthesiology
Zip code	236-0004
Address	236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2918
Homepage URL
Email	kikutyqdo1009@gmail.com

Sponsor
Institute	Yokohama City University School of Medicine. Department of Anesthesiology and Critical Care Medicine.
Institute
Department

Funding Source
Organization	Department of anesthesiology, Yokohama City University school of medicine
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	Institutional review board of Yokohama City University Hospital
Address	236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
Tel	045-370-7949
Email	ynextedu@yokohama-cu.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	2018 Year 04 Month 15 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	No longer recruiting
Date of protocol fixation	2018 Year 04 Month 05 Day
Date of IRB	2018 Year 04 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 23 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	2018 Year 04 Month 15 Day
Last modified on	2020 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036231