UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030174 |
|---|---|
| Receipt number | R000034464 |
| Scientific Title | Intermittent versus continuous local anesthetics administration in postoperative paravertebral block for patients undergoing video assisted thoracic surgery: a double blinded randomized controlled trial |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2019/11/25 10:07:43 |
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Basic information
Public title
Intermittent versus continuous local anesthetics administration in postoperative paravertebral block for patients undergoing video assisted thoracic surgery: a double blinded randomized controlled trial
Acronym
Intermittent versus continuous local anesthetics administration in postoperative paravertebral block for patients undergoing video assisted thoracic surgery: a double blinded randomized controlled trial
Scientific Title
Intermittent versus continuous local anesthetics administration in postoperative paravertebral block for patients undergoing video assisted thoracic surgery: a double blinded randomized controlled trial
Scientific Title:Acronym
Intermittent versus continuous local anesthetics administration in postoperative paravertebral block for patients undergoing video assisted thoracic surgery: a double blinded randomized controlled trial
Region
| Japan |
Condition
Condition
Diseases which need video assisted thoracic surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to compare the effects of intermittent or continuous administration of local anesthetics on postoperative analgesia in postoperative paravertebral block for patients undergoing video assisted thoracic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative dose of local anesthetics during postoperative 48 hours
Key secondary outcomes
1) Mean score of visual analogue scale (VAS) for pain during postoperative 6 hours
2) Satisfaction scores on VAS for postoperative 24 hours
3) Percentage of the patients showed signs or symptoms of local anesthetic 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
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Bolus administration of 15mL local anesthetics is repeated every 3 hours for up to 48 hours after surgery.
Interventions/Control_2
Local anesthetics administered continuously at a rate of 5 mL/h for up to 48 hours after surgery.
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 over 20 years old who will undergo video assisted thoracic surgery with postoperative paravertebral block
Key exclusion criteria
1. Patients who will undergo emergency surgery
2. Patients whose serum free local anesthetic concentration can easily be increased.
3. Patients whose paravertebral catheter is difficult to be inserted or to be confirmed the right position.
4. Patients who are inappropriate to be administered contrast medium.
5. Patients who cannot be interviewed after surgery
6. Patients who have allergy to drugs included in the study
7. Patients who suffered from unexpected complications of the surgery or anesthesia
8. Patients who are planned to be sedated after surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Fujii |
Organization
Wakayama Medical University
Division name
Dept. of Anesthesiology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama, Wakayama, Japan
TEL
073-441-0611
fujiik@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Fujii |
Organization
Wakayama Medical University
Division name
Dept. of Anesthesiology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama, Wakayama, Japan
TEL
073-441-0611
Homepage URL
fujiik@wakayama-med.ac.jp
Sponsor or person
Institute
Dept. of Anesthesiology, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.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
| 2017 | Year | 12 | Month | 01 | 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
26
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034464
