UMIN-CTR Clinical Trial

Basic information
Public title	Analgesic effect of the posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion: A randomized controlled trial
Acronym	Analgesic effect of posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion
Scientific Title	Analgesic effect of the posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion: A randomized controlledtrial
Scientific Title:Acronym	Analgesic effect of posterior spinal nerve medial branch block in posterior lumbar intervertebral fusion
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 posterior spinal nerve medial branch block in posterior intervertebral fusion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative pain scale(NRS)
Key secondary outcomes	The duration of the first additional analgesics

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	the posterior spinal nerve medial branch block
Interventions/Control_2	Without nerve 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing posterior intervertebral fusion
Key exclusion criteria	1)Patients who can not obtain research consent 2)Patients with previous spine surgery 3)Patients with allergies to local anesthetics 4)Liver failure 5)Renal failure 6)Heart failure
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Yoshimatsu
Organization	Ogikubo Hospital
Division name	Anesthesiology
Zip code	1670035
Address	3-1-24 Imagawa.Suginami-ku,Tokyo
TEL	0333991101
Email	user68545141@aol.com

Public contact
Name of contact person	1st name Takashi Middle name Last name Yoshimatsu
Organization	Ogikubo Hospital
Division name	Anesthesiology
Zip code	1670035
Address	3-1-24 Imagawa.Suginami-ku,Tokyo
TEL	0333991101
Homepage URL
Email	user68545141@aol.com

Sponsor
Institute	Ogikubo Hospital
Institute
Department

Funding Source
Organization	Ogikubo Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ogikubo Hospital
Address	3-1-24 Imagawa.Suginami-ku,Tokyo
Tel	0333991101
Email	chiken@ogikubo-hospital.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 08 Month 24 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	20
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	2019 Year 08 Month 22 Day
Date of IRB	2019 Year 10 Month 30 Day
Anticipated trial start date	2019 Year 10 Month 08 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 22 Day
Last modified on	2022 Year 10 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042943