UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060354 |
|---|---|
| Receipt number | R000069048 |
| Scientific Title | Efficacy of Tapering Programmed Intermittent Bolus in Quadratus Lumborum Block - Double-Blind Randomized Trial - |
| Date of disclosure of the study information | 2026/02/04 |
| Last modified on | 2026/01/14 16:58:19 |
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Basic information
Public title
Efficacy of Tapering Programmed Intermittent Bolus in Quadratus Lumborum Block - Double-Blind Randomized Trial -
Acronym
Efficacy of Tapering Programmed Intermittent Bolus in Quadratus Lumborum Block - Double-Blind Randomized Trial -
Scientific Title
Efficacy of Tapering Programmed Intermittent Bolus in Quadratus Lumborum Block - Double-Blind Randomized Trial -
Scientific Title:Acronym
Efficacy of Tapering Programmed Intermittent Bolus in Quadratus Lumborum Block - Double-Blind Randomized Trial -
Region
| Japan |
Condition
Condition
Hip Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares the efficacy of tapering programmed intermittent bolus (tPIB) versus continuous infusion (CI) in patients undergoing total hip arthroplasty (THA) under general anesthesia with quadratus lumborum block (QLB) for osteoarthritis of the hip.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analog Scale (VAS) at 24 hours and 48 hours post-surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Tapering Programmed Intermittent Bolus
Interventions/Control_2
Continuous infusion
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
Patients aged 20 years or older at the time of consent acquisition, patients scheduled for elective total hip arthroplasty (THA) under general anesthesia with spinal anesthesia for osteoarthritis of the hip, patients with an ASA-PS classification of Class I to III, and patients for whom written informed consent for participation in this study can be obtained.
Key exclusion criteria
Patients unable to report VAS scores, patients whose QLB was discontinued mid-procedure, patients with inadequate conduction anesthesia effect at the end of anesthesia, patients undergoing bilateral simultaneous surgery or reoperation, and patients deemed unsuitable by the principal investigator or co-investigator.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Tsutsumi |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Anesthesiology and Critical Care
Zip code
7340037
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
082-257-5267
yasuo223@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Tsutsumi |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Anesthesiology and Critical Care
Zip code
7340037
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
082-257-5267
Homepage URL
yasuo223@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi Minami-ku Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-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
| 2026 | Year | 02 | Month | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 12 | 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
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069048
