UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037930 |
|---|---|
| Receipt number | R000043232 |
| Scientific Title | The effect of difference in local anesthetic concentration used in continuous paravertebral block on thoracoscopic pulmonary resection on postoperative analgesic effect (a prospective randomized double-blind controlled study) |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2022/02/24 22:11:43 |
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Basic information
Public title
The effect of difference in local anesthetic concentration used in continuous paravertebral block on thoracoscopic pulmonary resection on postoperative analgesic effect (a prospective randomized double-blind controlled study)
Acronym
The effect of difference in local anesthetic concentration used in continuous paravertebral block on thoracoscopic pulmonary resection on postoperative analgesic effect (a prospective randomized double-blind controlled study)
Scientific Title
The effect of difference in local anesthetic concentration used in continuous paravertebral block on thoracoscopic pulmonary resection on postoperative analgesic effect (a prospective randomized double-blind controlled study)
Scientific Title:Acronym
The effect of difference in local anesthetic concentration used in continuous paravertebral block on thoracoscopic pulmonary resection on postoperative analgesic effect (a prospective randomized double-blind controlled study)
Region
| Japan |
Condition
Condition
Patients undergoing video-assisted thoracoscopic lung resection
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are various types and doses of local anesthetics used in the continuous paravertebral block after lung surgery. Previous meta-analysis has reported that higher concentration of bupivacaine administration is associated with higher analgesic effects. However, there is no report that directly compares the difference in analgesic effect due to the difference in concentration using levobupivacaine.
The purpose of this study is to compare whether postoperative analgesia using continuous paravertebral block in lung surgery results in a difference in analgesic effect due to concentrations of levobupivacaine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain score(Visual Analog Scale: VAS) for coughing in the morning following surgery
Key secondary outcomes
Resting VAS (0, 2, 4, 6, 8 hours after surgery, morning on the first day after surgery, morning on the second day after surgery)
VAS on coughing (2, 4, 6, 8 hours after surgery, morning on the second day after surgery)
Cold loss range (2 hours after surgery, morning on the first day after surgery)
Time when additional analgesics were administered from the postoperative day to the next morning, types of analgesics, and VAS
Patient age, height, weight, gender, American Society of Anesthesiology preoperative status classification
Surgery information (disease name, procedure, anesthesia time, operation time, fentanyl usage, remifentanil usage)
Postoperative side effects (nausea and vomiting, urinary retention, local anesthetic poisoning, etc.)
Complications (pneumothorax, vascular puncture, anaphylactic shock, etc.)
Patient satisfaction
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
| Maneuver |
Interventions/Control_1
Continuous paravertebral block (continuous administration of 0.25% levobupivacaine at 8 ml / hour for 2 days)
Interventions/Control_2
Continuous paravertebral block (continuous administration of 0.125% levobupivacaine at 8 ml / hour for 2 days)
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
| 16 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing thoracic pneumonectomy at Bellland General Hospital
Key exclusion criteria
Patients who do not agree to this clinical study
Maternity
Patients who cannot perform paravertebral block for the following reasons
1.Patients who are allergic to the drugs used (such as levobupivacaine and ropivacaine)
2.Patients undergoing anticoagulation therapy
3.Patient with infection at the puncture site
Patients who are judged inappropriate by the person in charge or joint researcher
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Horiuchi |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-ku, Sakai, Osaka
TEL
072-234-2001
t_horiuchi@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Kawase |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-ku, Sakai, Osaka
TEL
072-234-2001
Homepage URL
s_kawase@seichokai.or.jp
Sponsor or person
Institute
Department of Anesthesia, Bellland General 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
Bellland General Hospital Institutional Review Board
Address
500-3, Higashiyama, Naka-ku, Sakai, Osaka
Tel
072-234-2001
irb@seichokai.or.jp
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
| 2019 | Year | 09 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 05 | Month | 21 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043232
| Research Plan | |
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| Registered date | File name |
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