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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032255
Receipt No. R000036231
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.
Date of disclosure of the study information 2018/04/15
Last modified on 2019/06/15

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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, 9)Analesic drugs other than fentanyl and remifentanil.

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.
(6)Allergies of drugs used this study.
(7)Dementia.
(8)Cases which researchers judge inappropriate.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kikuchi Masaru
Organization Yokohama City University hospital
Division name Anesthesiology
Zip code
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
Middle name
Last name Kikuchi Masaru
Organization Yokohama City University hospital
Division name Anesthesiology
Zip code
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 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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 23 Day
Last follow-up date
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
2019 Year 06 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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