UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030658
Receipt number R000035002
Scientific Title Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.
Date of disclosure of the study information 2018/02/01
Last modified on 2019/10/16 22:10:36

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Basic information

Public title

Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.

Acronym

A prospective study of ultrasound-guided erector spinae plane block.

Scientific Title

Comparison of ultrasound-guided paravertebral block and erector spinae plane block in postoperative analgesia after video-assisted thoracoscopic surgery: a prospective, randomized, non-inferiority trial.

Scientific Title:Acronym

A prospective study of ultrasound-guided erector spinae plane block.

Region

Japan


Condition

Condition

Lung tumor

Classification by specialty

Chest surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Verifying the analgesic quality of ultrasound-guided continuous erector spinae plane block in video-assisted thoracic surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Numerical rating scale

Key secondary outcomes



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

Ultrasound-guided erector spinae plane block

Interventions/Control_2

Ultrasound-guided paravertebral block

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Provided written informed consent
2.American Society of Anesthesiologists physical status 1-3
3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung tumor.

Key exclusion criteria

Allergy to local anesthetics
BMI>40
Age< 20 or >86
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy

Target sample size

88


Research contact person

Name of lead principal investigator

1st name Taro
Middle name
Last name Fujitani

Organization

Ehime Prefectural Central Hospital

Division name

Department of Anesthesiology and Critical Care

Zip code

790-0024

Address

83 Kasuga-machi Matsuyama-city, Ehime 790-0024

TEL

+81-89-947-1111

Email

suko1231@yahoo.co.jp


Public contact

Name of contact person

1st name Yasuko
Middle name
Last name Taketa

Organization

Ehime Prefectural Central Hospital

Division name

Department of Anesthesiology and Critical Care

Zip code

7900024

Address

83 Kasuga-machi Matsuyama-city, Ehime 790-0024

TEL

+81-89-947-1111

Homepage URL


Email

suko1231@yahoo.co.jp


Sponsor or person

Institute

Ehime Prefectural Central Hospital

Institute

Department

Personal name



Funding Source

Organization

No funding

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

Institutional Review Board of Ehime Prefectural Hospital

Address

83 Kasuga-machi Matsuyama-city, Ehime 790-0024

Tel

+81-89-947-1111

Email

suko1231@yahoo.co.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

2018 Year 02 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

88

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

Main results already published

Date of protocol fixation

2018 Year 01 Month 24 Day

Date of IRB

2018 Year 02 Month 16 Day

Anticipated trial start date

2018 Year 02 Month 18 Day

Last follow-up date

2019 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 01 Day

Last modified on

2019 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name