UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037136
Receipt number R000042297
Scientific Title The study of clinical usefulness of Erector Spinae Plane block in spinal surgery
Date of disclosure of the study information 2019/06/25
Last modified on 2020/06/23 08:42:07

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Basic information

Public title

The study of clinical usefulness of Erector Spinae Plane block in spinal surgery

Acronym

The study of clinical usefulness of Erector Spinae Plane block in spinal surgery

Scientific Title

The study of clinical usefulness of Erector Spinae Plane block in spinal surgery

Scientific Title:Acronym

The study of clinical usefulness of Erector Spinae Plane block in spinal surgery

Region

Japan


Condition

Condition

Lumbar spine disease

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prospectively verify the usefulness of the erector spinae plane block in pain control after spinal surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Preoperative and postoperative pain scale(NRS)

Key secondary outcomes

Intraoperative drug use, Postoperative analgesic use


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In the block group, the spinae erector plane block is administered after induction of anesthesia. (Use 40 ml of 0.375% ropivacaine)

Interventions/Control_2

The control group performs anesthesia management as usual.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients who undergo lumbar spine surgery
2) ASA-PS 1 or 2
3) Patients with surgery time within 3 hours and surgery site up to 3
4) Regarding the participation in this research, the person has obtained written consent by free will

Key exclusion criteria

1) After lumbar spine posterior fixation surgery
2) Emergency operation patients
3) Patients who can not obtain research consent
4) Preoperative NRS is 7 or more
5) Patients judged to be inappropriate by the investigator or in charge of the research

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Shuji
Middle name
Last name Kurokawa

Organization

Konan Kosei Hospital

Division name

Anesthesiology

Zip code

4838703

Address

Takaya Town Omatsubara 137, Konan City, Aichi Prefecture

TEL

0587513333

Email

kurokawa@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Shuji
Middle name
Last name Kurokawa

Organization

Konan Kosei Hospital

Division name

Anesthesiology

Zip code

4838703

Address

Takaya Town Omatsubara 137, Konan City, Aichi Prefecture

TEL

0587513333

Homepage URL


Email

kurokawa@aichi-med-u.ac.jp


Sponsor or person

Institute

Konan Kosei Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Konan Kosei Hospital

Address

Takaya Town Omatsubara 137, Konan City, Aichi Prefecture

Tel

0587513333

Email

kurokawa@aichi-med-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2019 Year 06 Month 25 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

Open public recruiting

Date of protocol fixation

2019 Year 03 Month 01 Day

Date of IRB

2019 Year 03 Month 01 Day

Anticipated trial start date

2019 Year 03 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 06 Month 22 Day

Last modified on

2020 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042297


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name