UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005382 |
|---|---|
| Receipt number | R000006391 |
| Scientific Title | Intraoperative perineural infiltration of ropivacaine for acute postlaminectomy pain |
| Date of disclosure of the study information | 2011/04/05 |
| Last modified on | 2014/05/10 15:39:06 |
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Basic information
Public title
Intraoperative perineural infiltration of ropivacaine for acute postlaminectomy pain
Acronym
Intraoperative perineural infiltration of ropivacaine for acute postlaminectomy pain
Scientific Title
Intraoperative perineural infiltration of ropivacaine for acute postlaminectomy pain
Scientific Title:Acronym
Intraoperative perineural infiltration of ropivacaine for acute postlaminectomy pain
Region
| Japan |
Condition
Condition
lumbar spinal stenosis
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of analgestic effect, local infiltration (0.2%ropivacaine 10ml/one inter spinal segment)and continuous infusion of local anesthetics
(0.2%ropivacaine 6ml/h).
All patients receive NSAIDs .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
General anesthesia and NSAIDs.
As a contorol,saline 10ml infiltrate per one interspinal segment.
Interventions/Control_2
Generalanesthesia and NSAIDs.
0.2%ropivacaine 10ml infiltrate per one interspinal segment.
Interventions/Control_3
General anesthesia and NSAIDs.
From catheter in injury part,administration of 0.2%ropivacaine 6ml/h.
Duration of administration:2 days after the operation.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1,2
Patients scheduled laminactomy
Key exclusion criteria
AST ,ALT>30
Cr>2
reoperation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko kohno |
Organization
Higashi Ohmiya general hospital
Division name
anesthesiology
Zip code
Address
5-18,Higashiomiya,minuma-ku,Saitama city,Japan
TEL
0486847111
ykohno-ymi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko kohno |
Organization
Higashi Ohmiya general hospital
Division name
anesthesiology
Zip code
Address
5-18,Higashiomiya,minuma-ku,Saitama city,Japan
TEL
0486847111
Homepage URL
ykohno-ymi@umin.ac.jp
Sponsor or person
Institute
Higashi Ohmiya general hospital
Institute
Department
Personal name
Funding Source
Organization
Higashi Ohmiya general hospital
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
東大宮総合病院(埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 05 | 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
| 2010 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | 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
| 2011 | Year | 04 | Month | 05 | Day |
Last modified on
| 2014 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006391
