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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026842
Receipt No. R000030806
Scientific Title Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Date of disclosure of the study information 2017/04/05
Last modified on 2018/04/18

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Basic information
Public title Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Acronym Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Scientific Title Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Scientific Title:Acronym Comparison of the medication method of paravertebral block in thoracoscopic lung lobectomy
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of paravertebral block for postoperative analgesia and the different effect depend on the medication method of paravertebral block.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total amount of fentanyl which was injected by IV-PCA after the surgery
Key secondary outcomes The change of plasma concentration of regional anesthetic agents in both groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 0.25% levobupivacaine or 0.2% ropivacaine will be given after the surgery through the catheter of paravertebral block.
16 ml of a local anesthetic will be given every 8 hours until 48 hour after the surgery in a group of intermittently medication method.
Interventions/Control_2 0.25% levobupivacaine or 0.2% ropivacaine will be given after the surgery through the catheter of paravertebral block.
A local anesthetic was given with 6ml/hr until 48 hour after the surgery in a group of continuous medication method.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients of ASA physical status 1 or 2 scheduled for thoracoscopic lung lobectomy
Key exclusion criteria 1.Patients of ASA physical status 3 or 4.
2.Patients undergoing artifical dialysis.
3.Patients with hepatic failure.
4.Patients with infection
5.Patients with heart failur (NYHA 3 or 4)
6.patients with a pacemaker because of arrhythmia.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahashi Keiya
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 2-1-1-1 Midorigaoka-higashi,Asahikawa,Hokkaido,Japan
TEL 0166652111
Email k2341@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahashi Keiya
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code
Address 2-1-1-1 Midorigaoka-higashi,Asahikawa,Hokkaido,Japan
TEL 0166652111
Homepage URL
Email k2341@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Not applicable
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 05 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 07 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 04 Month 01 Day
Date trial data considered complete
2015 Year 04 Month 02 Day
Date analysis concluded
2015 Year 04 Month 06 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 03 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030806

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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