UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Title of the study (Brief title)	Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Region	Japan

Condition
Condition	patients scheduled for elective unilateral total knee arthroplasty under general anesthesia
Classification by specialty	Orthopedics Anesthesiology Operative medicine Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to compare peripheral nerve block with epidural analgesia in terms of analgesic efficacy, reduction of side effect from pain management method, and early knee rehabilitation after unilateral total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Day of knee flexion achievement above 120 degrees
Key secondary outcomes	Efficacy of postoperative pain management(VAS evaluation), Thigh and calf circumrefence, Rate of side effect Rehabilitation milestone(Ambulation with a cane, range of motion of operative knee) Frequency of Additional analgesia

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	<Group CFNB(continuous femoral nerve block)> Preoperative insertion of continuous femoral nerve block catheter and injection of 0.3% ropivacaine 60mg for continuous femoral nerve block and single-shot sciatic nerve block at the operative side (30mg ropivacaine respectively). Postoperative continuous infusion of 0.15% ropivacaine 4mL/h for 60 hours.
Interventions/Control_2	<Group CEI(continuous epidural infusion)> Preoperative insertion of epidural catheter at L3/4. Injection of 0.3% ropivacaine 90mg during surgery. Postoperative continuous infusion of 0.15% ropivacaine 4mL/h for 60 hours.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled unilateral total knee arthroplasty at Osaka University Medical Hospital.
Key exclusion criteria	Inability to communicate lucidly. Revision knee arthroplasty. Chronic pain syndrome unrelated to knee pathology. Allergy to local anesthetics. ASA phisical status above III. Chronic opioid use. Severe diabetes mellitus with sensory disorder. Neurologically-disabled. Contraindications to epidural analgesia or peripheral nerve block.
Target sample size	66

Research contact person
Name of lead principal investigator	Takaya Inoue
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesia and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	06-6879-3133
Email	sakayline@gmail.com

Public contact
Name of contact person	Norihiro Sakai
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesia and Intensive Care Medicine
Address	2-2 Yamadaoka, Suita City, Osaka, Japan
TEL	06-6879-3133
Homepage URL
Email	sakayline@gmail.com

Sponsor
Institute	Department of Anesthesia and Intensive Care Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self-funding
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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 07 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 07 Month 01 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2011 Year 07 Month 01 Day
Date of closure to data entry	2011 Year 07 Month 01 Day
Date trial data considered complete	2011 Year 08 Month 01 Day
Date analysis concluded	2011 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/23434107
Results
Other related information

Management information
Registered date	2010 Year 07 Month 13 Day
Last modified on	2018 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004415