UMIN-CTR Clinical Trial

Basic information
Public title	The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Acronym	The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Scientific Title	The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Scientific Title:Acronym	The effect of postoperative analgesia for post operative oxygenation in patients with interstitial pneumonia undergoing surgical biopasy
Region	Japan

Condition
Condition	Inetrstitial Pneumonia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is investigating the association betweeen postoperative analgesia (epidural anesthesia or intercostal nerve block) and postoperative oxygenation in patients with interstitial pneumonia undergoing surgical biopsy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of oxygen independent patients in each analgesia group.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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	Epidural anesthesia with continuous infusion of 0.2% ropivacaine.
Interventions/Control_2	Intra operative sigle shot 0.375% ropivacaine as intercostal nerve block and postoperative continuous intravenous infusion of fentanyl.
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 undergoing surgical lung biopsy for interstitial pneumonia, who admit to ICU after the opration.
Key exclusion criteria	Exclusion criteria:1) Patients who have contraindications to epidural anesthesia, 2) Patients underwent home oxygen therapy before the operation, 3) Patients who admit to ICU under tracheal intubation and mechanical ventilation.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Gamo
Organization	Kanagawa Cardiovascular and Respiratory Center
Division name	Department of Anesthesiology
Zip code
Address	6-16-1, Tomiokahigashi, Kanazawa-ku Yokohama-shi, Kanagawa, Japan
TEL	045-701-9581
Email	gamou@kanagawa-junko.jp

Public contact
Name of contact person	1st name Middle name Last name Natsuhiro Yamamoto
Organization	Yokohama City University
Division name	Department of Anesthesiology
Zip code
Address	3-9, Fukuura, Kanazawa-ku Yokohama-shi, Kanagawa, Japan
TEL	045-787-2918
Homepage URL
Email	natsuyamamo@gmail.com

Sponsor
Institute	Kanagawa Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	神奈川県立循環器呼吸器病センター

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 25 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	Terminated
Date of protocol fixation	2019 Year 01 Month 24 Day
Date of IRB	2018 Year 10 Month 15 Day
Anticipated trial start date	2019 Year 01 Month 24 Day
Last follow-up date	2019 Year 11 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 24 Day
Last modified on	2019 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040623