UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020401 |
|---|---|
| Receipt number | R000023560 |
| Scientific Title | Comparison of continuous and intermittent administration of patient controlled epidural analgesia after major joint replacement surgery |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2015/12/30 06:13:18 |
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Basic information
Public title
Comparison of continuous and intermittent administration of patient controlled epidural analgesia after major joint replacement surgery
Acronym
Epidural PIB study of TKA and THA
Scientific Title
Comparison of continuous and intermittent administration of patient controlled epidural analgesia after major joint replacement surgery
Scientific Title:Acronym
Epidural PIB study of TKA and THA
Region
| Japan |
Condition
Condition
Total hip arthroplasty and Total knee althroplasty
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this prospective, randomized, double-blinded study is to compare pain relief, side effects, and ability to ambulate during patient-controlled epidural analgesia with continuous versus intermittent administration mode after major joint replacement surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain score (VAS 0-100) of 0 to 3 POD
Pain interception level
Key secondary outcomes
the use of regional analgesics, the use of another analgesic methods, Patient satisfaction, Patient mobility and side effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A prospective, randomized, double-blinded, controlled trial
Comparing two protocols:
A)Continuous administration: 0.2%Ropivacaine 4ml/hr.
Interventions/Control_2
B)Intermittent administration: 0.2%Ropivacaine 6ml every 90 minutes
The PCA settings are common, bolus dose 3ml, lock out time 15 minutes.
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
elective unilateral TKA or THA
epidural and general anesthesia
age 20 to 90 year
ability to follow study protocol
ASA-PS 1 to 2.
Key exclusion criteria
contradiction for epidural anesthesia
chronic (>3 months) opioid use
allergies to local anesthetics
preexisting neuropathy on the limb decline to participate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayano Oiwa |
Organization
Toho University School of Medicine
Division name
Anesthesiology
Zip code
Address
6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
ayano.nakao@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayanoo Oiwa |
Organization
Toho University School of Medicine
Division name
Anesthesiology
Zip code
Address
6-11-1 Omori-Nishi Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
http://www.med.toho-u.ac.jp/gakunai/ethical_committee1/syonin_ichiran/index.html
ayano.nakao@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
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
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
| 2016 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 30 | Day |
Last modified on
| 2015 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023560
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
