UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018702 |
|---|---|
| Receipt number | 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 10:59:00 |
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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
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
m0028898@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City Graduate school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021644
