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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030464
Receipt No. R000034787
Scientific Title Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level.
Date of disclosure of the study information 2018/01/01
Last modified on 2018/12/25

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Basic information
Public title Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level.
Acronym Evaluation of the safety of infiltrationg the phrenic nerve at the vena azygos level.
Scientific Title Ispilateral shoulder pain after video-assisted thoracoscopy: a prospective, randomized, double-blind evaluation of the efficacy of infiltrationg the phrenic nerve at the vena azygos level.
Scientific Title:Acronym Evaluation of the safety of infiltrationg the phrenic nerve at the vena azygos level.
Region
Japan

Condition
Condition Patients who are scheduled for elective lobectomy or pneumonectomy for non-small cell lung cancer, aged > 18 years
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reduce the incidence of ipsilateral shoulder pain after video-assisted thoracoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative pain was assessed using an 11-point numeric rating scale(NRS)
Key secondary outcomes The excursion value of the shoulder
PONV

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Phrenic nerve block at the vena azygos level
Interventions/Control_2 Infiltrating the phrenic nerve with 0.375% ropivacaine before chest closure
Interventions/Control_3 Infiltrating the phrenic nerve, only once.
Interventions/Control_4 A post-operatively for 2 days observes total of 4 days from the way previous day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are scheduled for elective lobectomy or pneumonectomy for non-small cell lung cancer, aged > 18 years
Key exclusion criteria Patients with contrateral palsy, allergy to ropivacaine, pre-operative history of ipsilateral shoulder pain
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuroiwa Kaori
Organization Nagano Red Cross Hospital
Division name Departments of Anesthesia
Zip code
Address 5-22-1, Wakasato, Nagano, Japan
TEL 026-226-4131
Email anesthesi0hanz13@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuroiwa Kaori
Organization Nagano Red Cross Hospital
Division name Departments of Anesthesia
Zip code
Address 5-22-1, Wakasato, Nagano, Japan
TEL 026-226-4131
Homepage URL
Email anesthesi0hanz13@yahoo.co.jp

Sponsor
Institute Nagano Red Cross Hospital
Departments of Anesthesia
Institute
Department

Funding Source
Organization Nagano Red Cross Hospital
Departments of Anesthesia
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 長野赤十字病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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
2017 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2019 Year 01 Month 01 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 19 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034787

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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