UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Title of the study (Brief title)	The comparison of the efficasy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty.
Region	Japan

Condition
Condition	Osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the analgesic efficacy of selective tibial nerve block and periarticular infiltration analgesia for total knee arthroplasty when they are used with continuous femoral nerve block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The postoperative pain score (VAS) in 48 hours. The frequency of additional analgesics.
Key secondary outcomes	The frequency of postoperative peroneal nerve paralysis.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Perform selective tibial nerve block in addition to continuous femoral nerve block.
Interventions/Control_2	Perform periarticular infiltration analgesia in addition to continuous femoral nerve 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients undergoing unilateral total knee arthroplasty.
Key exclusion criteria	The case the patient did not consent. The critical organ failure like impairment of liver, kidney and heart. The severe psychiatric disorder. The patients taking analgesics except for knee pain. Rheumatoid arthritis. Any case with surgical complication intraoperatively. The case of failed femoral nerve block or postoperative catheter trouble.
Target sample size	70

Research contact person
Name of lead principal investigator	Katsuhiro Aikawa
Organization	Hokkaido university
Division name	Department of anesthesiology
Address	N15W7, Kita-ku, Sapporo, Hokkaido
TEL	011-706-7861(+81-11-706-7861)
Email	katsuhiro.aikawa@gmail.com

Public contact
Name of contact person	Katsuhiro Aikawa
Organization	Hokkaido university
Division name	Department of anesthesiology
Address	N15W7, Kita-ku, Sapporo, Hokkaido
TEL	011-706-7861(+81-11-706-7861)
Homepage URL
Email	katsuhiro.aikawa@gmail.com

Sponsor
Institute	Hokkaido university. Department of anesthesiology.
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	砂川市立病院（北海道）/Sunagawa city medical center (Hokkaido)

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 08 Day
Anticipated trial start date	2014 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 09 Month 30 Day
Last modified on	2017 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020709