UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050714 |
|---|---|
| Receipt number | R000057655 |
| Scientific Title | A double-blind, randomized, parallel-group study of the effect of topical additional dexamethasone of fascia iliaca compartment block (FICB) in proximal femoral fracture surgery |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2024/05/17 12:03:14 |
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Basic information
Public title
Study of the effect of steroid addition of nerve block in hip fracture surgery
Acronym
Study of the effects of steroid-added FICB
Scientific Title
A double-blind, randomized, parallel-group study of the effect of topical additional dexamethasone of fascia iliaca compartment block (FICB) in proximal femoral fracture surgery
Scientific Title:Acronym
Study of the effects of steroid-added FICB
Region
| Japan |
Condition
Condition
Proximal femoral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are a few reports that the addition of steroids is useful in prolonging the duration of effect of peripheral nerve blocks. In addition, reports of the benefit of FICB for analgesia in proximal femoral fracture surgery have been recognized. The purpose of this study is to evaluate whether the local addition of dexamethasone is effective in prolonging the analgesic effect, especially the duration of effect, of FICB in proximal femoral fracture surgery. We further assess the side effects of topical addition of dexamethasone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration from FICB administration to first as-needed analgesic administration
Key secondary outcomes
Number of doses of as-needed analgesics (within 48 hours from FICB)
Safety evaluation items:
Vital sign changes such as postoperative hypotension (within 48 hours from FICB)
Prolongation of motor block of the affected limb (within 48 hours from FICB)
Local infection (within 1 week after surgery)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the addition group: dexamethasone (Orgadrone Injection) 3.8mg(1ml) is added to the drug solution used for the previous FICB at our institution.
Interventions/Control_2
In the control group: FICB is performed as before.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who will be underwent proximal femoral fracture surgery under general anesthesia combined with ultrasound-guided FICB at our facility.
2.Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1.Patients who cannot complain of pain or patients who cannot administer NSAIDs or acetaminophen
2.Patients who received NSAIDs or acetaminophen within 3 hours before entering the operating room to immediately after surgery
3.Subjects who have diabetes or prone to infections
4.Others who have been determined ineligible by principal investigator or sub-investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shima |
| Middle name | |
| Last name | Taguchi |
Organization
Shimura Hospital
Division name
Department of Anesthesiology
Zip code
7340007
Address
3-13 Funairimachi, Naka-ku, Hiroshima-City 730-0841 Japan
TEL
+818019122416
yohtamam@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shima |
| Middle name | |
| Last name | Taguchi |
Organization
Shimura Hospital
Division name
Department of Anesthesiology
Zip code
7340007
Address
3-13 Funairimachi, Naka-ku, Hiroshima-City 730-0841 Japan
TEL
+818019122416
Homepage URL
yohtamam@hiroshima-u.ac.jp
Sponsor or person
Institute
Shimura Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimura 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
The institutional review board of Shimura Hospital
Address
3-13 Funairimachi, Naka-ku, Hiroshima-City 730-0841 Japan
Tel
0822945151
t-yossy@rc4.so-net.ne.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
| 2023 | Year | 04 | Month | 10 | 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
120
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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057655
