UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018578 |
|---|---|
| Receipt number | R000021255 |
| Scientific Title | Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomized, double-blind study |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2018/03/31 10:29:47 |
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Basic information
Public title
Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomized, double-blind study
Acronym
Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block
Scientific Title
Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block: a prospective, randomized, double-blind study
Scientific Title:Acronym
Effect of catheter tip location on the spread of sensory block produced by continuous thoracic paravertebral block
Region
| Japan |
Condition
Condition
Patients scheduled for a unilateral video-assisted thoracic surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the influence of paravertebral catheter tip location on the spread of sensory block that is produced by a continuous thoracic paravertebral block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of anesthetized dermatomes 24 h after surgery
Key secondary outcomes
Number of anesthetized dermatomes 2 h after surgery
Spread of contrast dye injected into the paravertebral space
Pain scale
Sedation level
Incidence of postoperative nausea and vomiting
Incidence of local anesthetic systemic toxicity
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
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Catheters will be inserted into the thoracic paravertebral space, where is ventral to the endothoracic fascia, under ultrasound guidance.
Interventions/Control_2
Catheters will be inserted into the thoracic paravertebral space, where is dorsal to the endothoracic fascia, under ultrasound guidance.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing video-assisted thoracic surgery at Niigata University Medical and Dental Hospital
2. Written informed consent is provided
Key exclusion criteria
1. American Society of Anesthesiologists Physical Status over 4
2. Inability to communicate lucidly
3. Under 20 or over 80 years old
4. Body Mass Index >30 kg/m^2
5. Body weight <40 kg
6. Contraindication or allergy to drugs used in this study
7. Renal or hepatic failure
8. Pre-existing sensory disturbance of the trunk
9. Patients requiring a posterolateral thoracotomy extending within 2 cm from the catheter insertion site
10. Previous ipsilateral thoracotomy
11. Infection at the catheter insertion site
12. Intrathoracic placement of the catheter
13. Patients who are regarded ineligible by researchers with any other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
ytaka@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
Homepage URL
ytaka@mac.com
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Anesthesiology, Niigata University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Self funding
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 02 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 02 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2018 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021255
