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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015589
Receipt No. 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

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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
Last 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
1st 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
Institute Hyogo Prefectural Amagasaki Hospital
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)

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
URL(English) https://upload.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


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