UMIN-CTR Clinical Trial

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
Email	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
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	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel	073-447-2300
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034464