UMIN-CTR Clinical Trial

Basic information
Public title	A comparative investigation about analgesic effect after modified TLIP block and infiltration for lumbar spinal surgery
Acronym	A comparative investigation about analgesic effect after modified TLIP block and infiltration for lumbar spinal surgery
Scientific Title	A comparative investigation about analgesic effect after modified TLIP block and infiltration for lumbar spinal surgery
Scientific Title:Acronym	A comparative investigation about analgesic effect after modifiedTLIP block and infiltration for lumbar spinal surgery
Region	Japan

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

Objectives
Narrative objectives1	effectiveness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative fentanyl administered for rescue analgesia during the first 48 hours after surgery
Key secondary outcomes	1. the pusched number of PCA for rescue analgesia during the firts 48 hours after surgery 2. the demand number of PCA push for rescue analgesia during the firts 48 hours after surgery 3. pain scores on the VAS at rest and during mobilization during the firts 48 hours after surgery 4. number of patients with complaints of complications such as nausea and vomiting during the first 48 hours after surgery.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	modified TLIP lock
Interventions/Control_2	Infiltration
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	secondary surgery spine surgery of more than 3 intervertebral space inability to cooperate and communicate allergies to local anesthetic
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, tokyo
TEL	03-3784-8575
Email	ueshimhi@med.showa-u.ac.jp

Public contact
Name of contact person	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, tokyo
TEL	03-3784-8575
Homepage URL
Email	ueshimhi@med.showa-u.ac.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, tokyo
Tel	03-3784-8575
Email	ueshimhi@med.showa-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 08 Month 16 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	76
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 08 Month 16 Day
Date of IRB	2017 Year 08 Month 16 Day
Anticipated trial start date	2017 Year 08 Month 16 Day
Last follow-up date	2019 Year 03 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 16 Day
Last modified on	2019 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032835