UMIN-CTR Clinical Trial

Basic information
Public title	Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial
Acronym	Analgesic effect of erector spinae plane block in spine surgery
Scientific Title	Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial
Scientific Title:Acronym	Analgesic effect of erector spinae plane block in spine surgery
Region	Japan

Condition
Condition	spine disease
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the analgesic effect of ultrasound-guided erector spinae plane (ESP) blockin spine surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	total postoperative fentanyl consumption in the first 24 h between the groups.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Bilateral ESP block with 15 ml 0.5% levobupivacaine at the L1-5 vertebral level is performed before general anesthesia in prone position.(Under 50 kg: 0.5% levobupivacaine 3 mg/kg)
Interventions/Control_2	General anesthesia without ESP block
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with elective lumbar spine surgery 2) ASA PS (American Society of Anesthesiologists physical status physical status):1-3 3) Obtaining consent form from patients
Key exclusion criteria	1) Emergency surgery 2) Patients with previous spine surgery 3) Spinal fusion surgery
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Noritaka Middle name Last name Imamachi
Organization	Shimane University
Division name	Department of Anesthesiology
Zip code	6938501
Address	89-1 Enyacho Izumo Shimane
TEL	0853202295
Email	imamachi@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Yawata
Organization	Shimane University
Division name	Anesthesiology
Zip code	6938501
Address	89-1 Enyacho Izumo Shimane
TEL	0853202295
Homepage URL
Email	shunsuke.tottorin@gmail.com

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Shimane University
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	Shimane University
Address	89-1 Enyacho Izumo Shimane
Tel	0853202295
Email	imamachi@med.shimane-u.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	2019 Year 02 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	2019 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date	2019 Year 02 Month 01 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	2019 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040660