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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028928
Receipt No. R000033046
Scientific Title Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Date of disclosure of the study information 2017/08/31
Last modified on 2019/08/09

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Basic information
Public title Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Acronym Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Scientific Title Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Scientific Title:Acronym Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Region
Japan

Condition
Condition Total hip replacement
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the analgesic effects of continuous quadratus lumborum block and femoral nerve block in patients after total hip replacement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain scores using visual analogue scale while movement at 24h after blocks
Key secondary outcomes Pain scores at rest and while movement at 6, 12, 24, 48h after blocks, while in the sitting position and stand
Times of analgesic use
Dermatomal sensory assessment
Motor disability
Time needed for block
Troubles related with catheter insertion
Postoperative nausea and vomitting

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Patinets receivescontinuous quadratus lumborum block transmuscular approach(group Q). When insertion of the catheter, we inject 30ml of 0.25% levobupibacaine. We start continuous infusion of 0.125%levobupibacaine 4ml/h as postoperative analgesia for two days.
Interventions/Control_2 Patinets receives continuous femoral nerve block(group F). When insertion of the catheter, we inject 15ml of 0.5% levobupibacaine for group F. We start continuous infusion of 0.125%levobupibacaine 4ml/h as postoperative analgesia for two 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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who schedulled of total hip replacement with general anesthesia.
American Society of Anesthesiologists physical status 1~3.
Key exclusion criteria neural disturbance at the lumbar region and lower extremity
preoperative use of opiate analgesics
allergy to medications used for study
severe cognitive impairment
revision arthroplasty of the same side
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 0853-20-2295
Email ssakura@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Sakura
Organization Shimane University Hospital
Division name operation department
Zip code 693-8501
Address 89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL 0853-20-2295
Homepage URL
Email ssakura@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of 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 Shimane University Hospital, Clinical Trial Review Board
Address 89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel +81-853-20-2515
Email kenkyu@med.shimane-u.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 08 Month 31 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 30
Results
The Analgesic effects of continuous QLB were not superior to those of continuous FNB in patients undergoing THA.
Results date posted
2019 Year 08 Month 09 Day
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
2017 Year 08 Month 28 Day
Date of IRB
2017 Year 08 Month 28 Day
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
2019 Year 06 Month 30 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 08 Month 31 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033046

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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