UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026842 |
|---|---|
| Receipt number | 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 21:03:11 |
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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
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
k2341@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030806
