UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028681
Receipt No. R000032835
Scientific Title A comparative investigation about analgesic effect after modified TLIP block and infiltration for lumbar spinal surgery
Date of disclosure of the study information 2017/08/16
Last modified on 2019/11/10

* 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 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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.