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
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
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
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
