UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022532 |
|---|---|
| Receipt number | R000023302 |
| Scientific Title | The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2018/11/30 14:16:34 |
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Basic information
Public title
The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Acronym
The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Scientific Title
The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Scientific Title:Acronym
The efficacy of automated intermittent thoracic paravertebral bolus technique for analgesia after thoracotomies: prospective, randomized, controlled, double-blind study
Region
| Japan |
Condition
Condition
Adult patients scheduled for elective unilateral thoracotomy (lung lobectomy or pulmonary segmentectomy) under combination of general anesthesia and thoracic paravertebral block
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine if an automated intermittent thoracic paravertebral bolus decreases post-thoracotomy pain more effectively when compared with a continuous thoracic paravertebral infusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anesthetized dermatomes by thoracic paravertebral block 24 h after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Postoperative continuous thoracic paravertebral infusion of 0.2% levobupivacaine at 5 ml/h for 48 h
Interventions/Control_2
Postoperative automated intermittent thoracic paravertebral bolus of 0.2% levobupivacaine 10 ml every 2 hours for 48 h
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 elective unilateral lung lobectomy or pulmonary segmentectomy at Nagasaki University Hospital
2.American Society of Anesthesiologists Physical Status Classification I-III
3.Patients signed the informed consent form
Key exclusion criteria
1.Age < 20 or > 80 years
2.Prior thoracotomy on ipsilateral side
3.Body mass index > 30 kg/m2
4.Body weight < 40 kg
5.Allergy to local anesthetics
6.Contraindication to non-steroidal anti-inflammatory drugs, fentanyl, iodinated contrast medium
7.Hepatic or renal failure
8.Chronic opioid use
9.Pre-existing neurological deficit
10.Infection at the site of injection
11.Bronchial asthma
12.Inability to communicate lucidly
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Murata |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Anesthesiology
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7370
h-murata@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Murata |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Anesthesiology
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7370
Homepage URL
h-murata@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Nagasaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Smiths Medical Japan Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
| 2016 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 12 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023302
