UMIN-CTR Clinical Trial

Basic information
Public title	Posterior medial quadratus lumborum block provided effective analgesia for lumbar spinal surgery: A Randomized Controlled Trial
Acronym	Posterior medial quadratus lumborum block provided effective analgesia for lumbar spinal surgery: A Randomized Controlled Trial
Scientific Title	Posterior medial quadratus lumborum block provided effective analgesia for lumbar spinal surgery: A Randomized Controlled Trial
Scientific Title:Acronym	Posterior medial quadratus lumborum block provided effective analgesia for lumbar spinal surgery: A Randomized Controlled Trial
Region	Japan

Condition
Condition	Lumbar spinal surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analgesic efficacy in perioperative period
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cumulative fentanyl consumption administered for rescue analgesia during the first 24 hours after surgery.
Key secondary outcomes	1.The number of fentanyl demands and delivered for rescue analgesia 2.The Extent of sensory blockade related to the posterior branches of lumbar spinal nerve (cold tests) 3. The pain score on the visual analogue scale (VAS) at rest and during mobilization in the first 48 hours after surgery. 4. The number of patients who complaint of nausea and vomiting during the first 24 hours after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Posterior medial quadratus lumborum block with general anesthesia (Q group)
Interventions/Control_2	Placebo posterior medial quadratus lumborum block with general anesthesia (C group)
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	Lumbar spinal surgery
Key exclusion criteria	lumbar spinal surgery more than three levels revision surgery chronic opioids preoperatively for more than three months Allergic to levobupivacaine. Reoperation during the first fotry-eight hours postoperative
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Ueshima
Organization	Showa university hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8, hatanodai, shinagawa-ku
TEL	0337848575
Email	ueshimhi@yahoo.co.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Ueshima
Organization	Showa university hospital
Division name	Amesthesiology
Zip code	142-8666
Address	1-5-8, hatanodai, shinagawa-ku
TEL	0337848575
Homepage URL
Email	ueshimhi@yahoo.co.jp

Sponsor
Institute	Showa university hospital
Institute
Department

Funding Source
Organization	Showa university hospital
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	Showa university hospital
Address	1-5-8, hatanodai, shinagawa-ku
Tel	0337848575
Email	ueshimhi@yahoo.co.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	2020 Year 02 Month 21 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	73
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	Suspended
Date of protocol fixation	2018 Year 04 Month 13 Day
Date of IRB	2018 Year 04 Month 13 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2021 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	2020 Year 02 Month 21 Day
Last modified on	2020 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045111