UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005382
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ykohno-ymi@umin.ac.jp

Sponsor
Institute Higashi Ohmiya general hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006391

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.