UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008729 |
|---|---|
| Receipt number | R000010246 |
| Scientific Title | Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2018/03/31 10:26:36 |
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Basic information
Public title
Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Acronym
Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Scientific Title
Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Scientific Title:Acronym
Effect of ropivacaine concentration on the distribution of neural blockade in continuous thoracic paravertebral block
Region
| Japan |
Condition
Condition
Patients scheduled for elective unilateral thoracotomy (lung lobectomy or pulmonary segmentectomy) under general anesthesia and continuous thoracic paravertebral block
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this prospective and randomized study, we evaluate the number of anesthetized dermatomes and the quality of postoperative analgesia produced by a continuous thoracic paravertebral infusion of 0.2% ropivacaine 6 mL/h compared with 0.5% ropivacaine 6mL/h after thoracic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of anesthetized dermatomes 24 hours after surgery
Key secondary outcomes
1.Pain score (Numerical Rating Scale) assessed at 1 hour, 6, 24, and 48 hours after surgery
2.The consumption of additional analgesics
3.Patient satisfaction score
4.Sedation score (Richmond Agitation Sedation Scale)
5.Incidence of nausea and vomiting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
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
| Medicine |
Interventions/Control_1
Postoperative continuous thoracic paravertebral block of ropivacaine 0.2% 6mL/h for 48 hours
Interventions/Control_2
Postoperative continuous thoracic paravertebral block of ropivacaine 0.5% 6mL/h for 48 hours
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 unilateral lung lobectomy or pulmonary segmentectomy at Niigata University Medical and Dental Hospital
2.American Society of Anesthesiologists Physical Status Classification I-III
3.Written informed consent is provided
Key exclusion criteria
1. Inability to communicate lucidly
2. Under 20 years old or over 80 years old
3. Bilateral thoracotomy
4. Patient with a past history of thoracotomy on the same side as the surgery
5. Allergy to local anesthetics
6. Contraindication to NSAIDs or fentanyl
7. ASA-PS > III
8. Hemodialysis patients
9. Body Mass Index > 30 kg/m^2
10. Body weight < 40 kg
11. Chronic opioid use
12. Neurological disability
13. Infections at the site of injection
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Baba |
Organization
Niigata University Graduate School of Medical and Dental Science
Division name
Department of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
baba@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
Homepage URL
ytaka@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
| 2011 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 24 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | 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=R000010246
