UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of ultrasound guided femoral nerve block and adductor canal block for postoperative analgesia after total knee arthroplasty
Acronym	Comparison of ultrasound guided femoral nerve block and adductor canal block for postoperative analgesia after total knee arthroplasty
Scientific Title	Comparison of ultrasound guided femoral nerve block and adductor canal block for postoperative analgesia after total knee arthroplasty
Scientific Title:Acronym	Comparison of ultrasound guided femoral nerve block and adductor canal block for postoperative analgesia after total knee arthroplasty
Region	Japan

Condition
Condition	patients receiving bilateral total knee arthroplasty
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare femoral nerve block and adductor canal block for influence on postoperative analgesia and rehabilitation after bilateral TKA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Postoperative 24h Numerical Rating Scale(NRS) at rest
Key secondary outcomes	Postoperative NRS at rest (0,6,12,48h) Postoperative NRS during knee movement (0,6,12,24,48h) Postoperative Range of Motion (ROM)(12,24,48h) Postoperative effect of Sciatic nerve block (0,12,24h)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and 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	Femoral nerve block
Interventions/Control_2	Adductor canal block
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients scheduled bilateral total knee arthroplasty
Key exclusion criteria	history of complications Patients who can not evaluate NRS Patients with local anesthetics allergy
Target sample size	46

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	kyokui090018@gmail.com

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	kyokui090018@gmail.com

Sponsor
Institute	Asahikawa Medical University Anesthesiology and Critical Care Medicine
Institute
Department

Funding Source
Organization	Asahikawa Medical University Anesthesiology and Critical Care 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	Asahkawa Medical University
Address	Midorigaoka-higashi 2-1-1-1,Asahikawa,Hokkaido,Japan
Tel	0166682297
Email	rs-kk.g@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	2018 Year 01 Month 25 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 10 Month 20 Day
Date of IRB	2017 Year 10 Month 27 Day
Anticipated trial start date	2017 Year 11 Month 20 Day
Last follow-up date	2022 Year 09 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	2018 Year 01 Month 25 Day
Last modified on	2021 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034979