UMIN-CTR Clinical Trial

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
Email	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
Email	s_kawase@seichokai.or.jp

Sponsor
Institute	Department of Anesthesia, Bellland General Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043232