UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032255 |
|---|---|
| Receipt number | R000036231 |
| Scientific Title | The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial. |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2020/11/25 12:45:26 |
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Basic information
Public title
The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Acronym
The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Scientific Title
The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Scientific Title:Acronym
The efficacy of the Quadratus Lumborum Block anterior approach for the postoperative recovery after Total Hip Arthroplasty. A single-center, double-blinded, randomized controlled trial.
Region
| Japan |
Condition
Condition
Hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the efficacy of the Quadratus Lumborum BLock for the postoperative recovery after Total Hip Arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Recovery 40 score 24 hours after surgery.
Key secondary outcomes
1)Fentanyl consumption until 24 hours after surgery, 2)Number of times of use IV-PCA, 3)Pain at rest and effort on postoperative day1, 2(VAS), 4)Post operative nausea and vomit, 5)Intraoperative consumption of fentanyl, 6)Duration of first use of PCA, 7)Intraoperative consumption of remifentanil, 8)The frequency and dose of other analgesic requirements(i.e, flurbiprofen axetil of diclofenac), 9)The time of first ambulation, 10)The manual muscle test (MMT) results for the quadriceps muscle during day 1 of postoperative rehabilitation, 11)Perioperative complications related to surgical or anesthetic procedures (i.e, wound infection, bleeding, dislocation, reoperation, nerve injury, hypotension, or falling), 12)Days in hospital
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Injecting 0.25% levobupivacaine 30ml under ultrasound-guided Quadratus Lumborum Block anterior approach.
Interventions/Control_2
Injecting normal saline under ultrasound-guided Quadratus Lumborum Block anterior approach.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Age over 20 years.
(2)Scheduled to unilateral total hip arthroplasty.
(3)ASA-PS1-2
(4)Written informed consent of this study.
Key exclusion criteria
(1)Revision cases.
(2)Dysfunction of liver and kidney.
(3)Coagulopathy.
(4)BMI>35
(5)Strong opioid user such as morphine or fentanyl
(6)Allergies to study drugs and their components
(7)Dementia.
(8)Cases judged to inappropriate by the researchers. For instance, cases where the patient has undergone other femoral surgeries such as intramedullary nailing.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kikuchi |
Organization
Yokohama City University hospital
Division name
Anesthesiology
Zip code
236-0004
Address
236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-787-2918
kikutyqdo1009@gmail.com
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Kikuchi |
Organization
Yokohama City University hospital
Division name
Anesthesiology
Zip code
236-0004
Address
236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-787-2918
Homepage URL
kikutyqdo1009@gmail.com
Sponsor or person
Institute
Yokohama City University School of Medicine. Department of Anesthesiology and Critical Care Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology, Yokohama City University school of medicine
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
Institutional review board of Yokohama City University Hospital
Address
236-0004 Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
Tel
045-370-7949
ynextedu@yokohama-cu.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
| 2018 | Year | 04 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | 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
| 2018 | Year | 04 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036231
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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