UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028681 |
|---|---|
| Receipt number | 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 16:23:13 |
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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
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
ueshimhi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032835
