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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003910
Receipt No. R000004415
Scientific Title Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Date of disclosure of the study information 2010/07/15
Last modified on 2018/03/25

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Basic information
Public title Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Acronym Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Scientific Title Effects of epidural analgesia and peripheral nerve block on postoperative analgesia and early knee rehabilitation after total knee arthroplasty
Scientific Title:Acronym 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
1st name
Middle name
Last name Takaya Inoue
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesia and Intensive Care Medicine
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka, Japan
TEL 06-6879-3133
Email sakayline@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Norihiro Sakai
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesia and Intensive Care Medicine
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23434107
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 Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
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

Other
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

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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