UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015589
Receipt number R000018099
Scientific Title A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery
Date of disclosure of the study information 2014/11/10
Last modified on 2016/11/04 10:35:27

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Basic information

Public title

A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery

Acronym

A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery

Scientific Title

A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery

Scientific Title:Acronym

A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery

Region

Japan


Condition

Condition

primary lung cancer, metastatic lung cancer, benign tumor of the lung, pneumothorax

Classification by specialty

Chest surgery Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We compare the efficacy of retrolaminar block and paravertbral block for pain relief after lung surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

We measure postoperative pain severity on coughing by Numerical Rating Scale (NRS, 0-10) after 1 hour and 2 hours of the operation. Then, we convert the NRSs to 0-100 mm scale. Our primary outcome is area under the curve of the converted NRSs.

Key secondary outcomes

Postoperative pain severity at rest measured by Numerical Rating Scale
Cumulative morphine consumption
Procedure duration
Postoperative duration free of morphine rescue
Postoperative nausea and vomiting


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

retrolaminar block

Interventions/Control_2

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Adult patients scheduled to undergo lung surgery under general anesthesia.
Video-assisted thoracoscopic surgery or small incisional thoracotomy.
American Society of Anesthesiologists physical status class I or II

Key exclusion criteria

Allergy to ropivacaine or flurbiprofen.
Bronchial asthma.
American Society of Anesthesiologists physical status class III or more.
Patient's refusal to consent

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Shindo, M. D.

Organization

Hyogo Prefectural Amagasaki Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-1-1, Higashidaimotsu-cho, Amagasaki-shi, Hyogo 660-0828, Japan

TEL

06-6482-1521

Email

kshindo@amahosp.amagasaki.hyogo.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuji Sugiyama, M.D.

Organization

Hyogo Prefectural Amagasaki Hospital

Division name

Department of Anesthesiology

Zip code


Address

1-1-1, Higashidaimotsu-cho, Amagasaki-shi, Hyogo 660-0828, Japan

TEL

06-6482-1521

Homepage URL


Email

tacousi@hotmail.com


Sponsor or person

Institute

Hyogo Prefectural Amagasaki Hospital

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


Email



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

兵庫県立尼崎病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 10 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

Completed

Date of protocol fixation

2014 Year 10 Month 16 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 10 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

2014 Year 11 Month 03 Day

Last modified on

2016 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name