UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039557 |
|---|---|
| Receipt number | R000045111 |
| Scientific Title | Posterior medial quadratus lumborum block provided effective analgesia for lumbar spinal surgery: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2020/04/02 15:37:23 |
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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
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
ueshimhi@yahoo.co.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
Tel
0337848575
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045111
