UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050676 |
|---|---|
| Receipt number | R000057715 |
| Scientific Title | The median effective concentration of ropivacaine for ultrasound-guided suprainguinal fascia iliaca compartment block for preoperative pain management in elderly patients with hip fracture |
| Date of disclosure of the study information | 2023/03/25 |
| Last modified on | 2024/02/01 11:22:47 |
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Basic information
Public title
The median effective concentration of ropivacaine for ultrasound-guided suprainguinal fascia iliaca compartment block for preoperative pain management in elderly patients with hip fracture
Acronym
MEC of ropivacaine in SFICB
Scientific Title
The median effective concentration of ropivacaine for ultrasound-guided suprainguinal fascia iliaca compartment block for preoperative pain management in elderly patients with hip fracture
Scientific Title:Acronym
MEC of ropivacaine in SFICB
Region
| Asia(except Japan) |
Condition
Condition
Inpatients 75 years of age or older with acute hip fracture were recruited into the study.
Classification by specialty
| Geriatrics | Orthopedics | Anesthesiology |
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the 50% effective concentration (ED50) of ropivacaine to achieve successful preperative pain management for ultrasound-guided suprainguinal fascia iliaca compartment blockade in elderly patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes was a successful analgesia (in the initial 24 hr after procedure, the exercising visual analog scale score < 4).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A concentration of 30 ml ropivacaine administered to the suprainguinal fascia iliaca compartment was measured by applying the up and down sequential method. The starting concentration was 0.35 % in the first patient, and increases or decreases in the concentration of ropivacaine were set at 0.025% on the basis of the response of the previous patient (effective or ineffective). The study was concluded when 7 crossovers occurred.
Interventions/Control_2
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
| 75 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were patients 75 years of age or older with acute hip fracture.
Key exclusion criteria
The exclusion criteria were 1) weighing less than 35kg, 2) any serious systemic disease, 3) manifesting coagulopathy or receiving anticoagulants, 4) known hypersensitivity to ropivacaine, 5) a history of chronic pain or preoperative chronic use of analgesics, 6) an infection in the area where FICB was to be performed, 7) neurological or neuromuscular disease, and 8) dementia or having significant visual, hearing, or cognitive impairment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
Affiliated Banan Hospital of Chongqing Medical University
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
cjandsh@tmmu.edu.cn
Public contact
Name of contact person
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
Affiliated Banan Hospital of Chongqing Medical University
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
Homepage URL
cjandsh@tmmu.edu.cn
Sponsor or person
Institute
Department of Anaesthesiology, Affiliated Banan Hospital of Chongqing Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anaesthesiology, Affiliated Banan Hospital of Chongqing Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Affiliated Banan Hospital of Chongqing Medical University
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing 401320, P.R China
Tel
+81-086-23-66291798
409560509@qq.com
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 | 03 | Month | 25 | 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
28
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 25 | 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 | 25 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057715
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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