UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028928 |
|---|---|
| Receipt number | R000033046 |
| Scientific Title | Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2019/08/09 12:45:20 |
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Basic information
Public title
Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Acronym
Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Scientific Title
Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Scientific Title:Acronym
Continuous transmuscular quadratus lumborum block and femoral nerve block for analgesia after total hip replacement: a prospective, randomized controlled study
Region
| Japan |
Condition
Condition
Total hip replacement
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the analgesic effects of continuous quadratus lumborum block and femoral nerve block in patients after total hip replacement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain scores using visual analogue scale while movement at 24h after blocks
Key secondary outcomes
Pain scores at rest and while movement at 6, 12, 24, 48h after blocks, while in the sitting position and stand
Times of analgesic use
Dermatomal sensory assessment
Motor disability
Time needed for block
Troubles related with catheter insertion
Postoperative nausea and vomitting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patinets receivescontinuous quadratus lumborum block transmuscular approach(group Q). When insertion of the catheter, we inject 30ml of 0.25% levobupibacaine. We start continuous infusion of 0.125%levobupibacaine 4ml/h as postoperative analgesia for two days.
Interventions/Control_2
Patinets receives continuous femoral nerve block(group F). When insertion of the catheter, we inject 15ml of 0.5% levobupibacaine for group F. We start continuous infusion of 0.125%levobupibacaine 4ml/h as postoperative analgesia for two days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who schedulled of total hip replacement with general anesthesia.
American Society of Anesthesiologists physical status 1~3.
Key exclusion criteria
neural disturbance at the lumbar region and lower extremity
preoperative use of opiate analgesics
allergy to medications used for study
severe cognitive impairment
revision arthroplasty of the same side
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University Hospital
Division name
operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
0853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University Hospital
Division name
operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
0853-20-2295
Homepage URL
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Shimane University Hospital, Clinical Trial Review Board
Address
89-1 Enya-cho, Izumo-shi, Shimane, Japan
Tel
+81-853-20-2515
kenkyu@med.shimane-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 | 31 | 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
30
Results
The Analgesic effects of continuous QLB were not superior to those of continuous FNB in patients undergoing THA.
Results date posted
| 2019 | Year | 08 | Month | 09 | Day |
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 | 28 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | 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 | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033046
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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