UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035698
Receipt No. R000040660
Scientific Title Analgesic effect of erector spinae plane block in spine surgery: A randomized controlled trial
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/28

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Noritaka Imamachi
Organization Shimane University
Division name Department of Anesthesiology
Zip code
Address 89-1 Enyacho Izumo Shimane
TEL 0853202295
Email imamachi@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Yawata
Organization Shimane University
Division name Anesthesiology
Zip code
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
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
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
2019 Year 01 Month 28 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.