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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018702
Receipt No. R000021644
Scientific Title The randomized study about pain relief after spinal surgery with the conduction block of dorsal rami with Ropivacain
Date of disclosure of the study information 2015/08/17
Last modified on 2016/11/28

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Basic information
Public title The randomized study about pain relief after spinal surgery with the conduction block of dorsal rami with Ropivacain
Acronym CBDRR study
Scientific Title The randomized study about pain relief after spinal surgery with the conduction block of dorsal rami with Ropivacain
Scientific Title:Acronym CBDRR study
Region
Japan

Condition
Condition Lumbar spinal stenosis (LSS)
Cervical spondylotic myelopathy (CSM)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For the patients who receive spinal surgery, we will perform subcutaneous and inter-paraspinal injection of Ropivacain (the conduction block of dorsal rami), and prospectively analyze whether this therapy reduce postoperative pain, or decrease the dosage amount of additional NSAIDs or weak opioid analgesics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Visual analog scale (VAS) for wound pain at 48 hours after surgery
Key secondary outcomes VAS for the wound pain at 4, 12, 24, 36, 72 hours and 7, 14days after surgery.
VAS for the back or neck pain at 3 months after surgery.
The type and dosage amount of additional pain-killers.
Complication.
VAS for upper or lower extremity.
JOA score, JOABPEQ, JOACMEQ

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We will perform the subcutaneous and inter-paraspinal injection of Ropivacain immediately before the wound closure of spine surgery.
Interventions/Control_2 We don't perform the injection.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) The patients who will receive surgery as follows
*Microendoscopic laminotomy, or microscopic bilateral decompression via unilateral approach for lumbar spinal stenosis
*Laminoplasty for cervical spondylotic myelopathy
2) The patients who were explained and understood well about this survey, in addition, give written informed consent of their own free will.
Key exclusion criteria These patients are excluded
1) Coexisting malignant tumors
2) Pyogenic spondylitis
3) Severe hepatic disorders
4) Severe renal disorders
5) Cardiac conduction abnormalities
6) Allergic history of the ropivacain
7) Lactating women
8) Received ropivacain within 3 months before our injection
9) Received IVH perioperatively
10) Anyone who disqualified by the doctor in charge
Target sample size 280

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hoshino / Kazunori Hayashi
Organization Osaka City Graduate school of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan
TEL 06-6645-3851
Email m0028898@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Hayashi
Organization Osaka City Graduate school of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka, Japan
TEL 06-6645-3851
Homepage URL
Email m0028898@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City Graduate school of Medicine
Institute
Department

Funding Source
Organization None
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 大阪市立大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 17 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
2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 17 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 08 Month 17 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021644

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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