UMIN-CTR Clinical Trial

Basic information
Public title	The coparison of postoperative analgeisia between quadratus lumborum block and epidural block
Acronym	QLB and epidural block
Scientific Title	The coparison of postoperative analgeisia between quadratus lumborum block and epidural block
Scientific Title:Acronym	QLB and epidural block
Region	Japan

Condition
Condition	the patient who receive nephrectomy or partial nephrectomy
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To comapre the postoperative analgesia between epidural block and quadrates lumborum block
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	amount of IV-PCA fentayl
Key secondary outcomes	Visual analogue scale of resting and moving pain

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	epidural block
Interventions/Control_2	quadratus lumborum 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	Not applicable
Gender	Male and Female
Key inclusion criteria	the patients who received nephrectomy and partial nephrectomy
Key exclusion criteria	> ASA class 3
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Goyagi
Organization	Akita University Graduate School of Medicine
Division name	Anesthesia and Intensive Care Medicine
Zip code	010-8543
Address	1-1-1, Hondo, Akita-city, Akita
TEL	018-884-6175
Email	tgoyagi@doc.med.akita-u.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Goyagi
Organization	Akita University Graduate School of Medicine
Division name	Anesthesia and Intensive Care Medicine
Zip code	010-8543
Address	1-1-1, Hondo, Akita-city, Akita,
TEL	018-884-6175
Homepage URL
Email	tgoyagi@doc.med.akita-u.ac.jp

Sponsor
Institute	Akita University
Institute
Department

Funding Source
Organization	Akita 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	IRB
Address	1-1-1, Hondo, Akita-city, Akita,
Tel	018-884-6216
Email	soken@hos.akita-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	2017 Year 04 Month 10 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	Completed
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 03 Month 20 Day
Anticipated trial start date	2017 Year 04 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 04 Month 08 Day
Last modified on	2021 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030740