UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized non-inferiority controlled trial of retrolaminar block versus paravertbral block for pain relief after lung surgery
Title of the study (Brief title)	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	Kazuo Shindo, M. D.
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Anesthesiology
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	Takuji Sugiyama, M.D.
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018099