UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized study about pain relief after spinal surgery with the conduction block of dorsal rami with Ropivacain
Title of the study (Brief title)	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	Masatoshi Hoshino / Kazunori Hayashi
Organization	Osaka City Graduate school of Medicine
Division name	Department of Orthopedic Surgery
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	Kazunori Hayashi
Organization	Osaka City Graduate school of Medicine
Division name	Department of Orthopedic Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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