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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030174
Receipt No. 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 2017/11/29

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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
Middle name
Last name Keisuke Fujii
Organization Wakayama Medical University
Division name Dept. of Anesthesiology
Zip code
Address 811-1, Kimiidera, Wakayama, Wakayama, Japan
TEL 073-441-0611
Email fujiik@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Fujii
Organization Wakayama Medical University
Division name Dept. of Anesthesiology
Zip code
Address 811-1, Kimiidera, Wakayama, Wakayama, Japan
TEL 073-441-0611
Homepage URL
Email fujiik@wakayama-med.ac.jp

Sponsor
Institute Dept. of Anesthesiology, Wakayama Medical University
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
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
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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