UMIN-CTR Clinical Trial

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

Lumbar spinal stenosis (LSS)
Cervical spondylotic myelopathy (CSM)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Osaka City Graduate school of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪市立大学医学部付属病院

Date of disclosure of the study information

2015

Year

08

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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