UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043694 |
|---|---|
| Receipt number | R000049892 |
| Scientific Title | Effect of orientation of lateral position on spinal anesthesia for proximal femoral fractures |
| Date of disclosure of the study information | 2021/03/24 |
| Last modified on | 2023/02/10 16:32:10 |
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Basic information
Public title
Effect of orientation of lateral position on spinal anesthesia for proximal femoral fractures
Acronym
Effect of orientation of lateral position on spinal anesthesia for proximal femoral fractures
Scientific Title
Effect of orientation of lateral position on spinal anesthesia for proximal femoral fractures
Scientific Title:Acronym
Effect of orientation of lateral position on spinal anesthesia for proximal femoral fractures
Region
| Japan |
Condition
Condition
proximal femoral fractures
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether orientation of spinal anesthesia affects pain in patients with proximal femoral fractures (femoral neck fracture, femoral trochanteric fracture).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage (%) of strong pain (Pain score 3 points or more) when changing from supine to lateral position
Pain score using this study is as follows:
0: calm
1: facial grimacing
2: moaning
3: screaming
4: unable to proceed
Key secondary outcomes
1. Changes in heart rate during positioning
2. Pain score
3. Quality of position for spinal anesthesia (1: unsatisfactory, 2: satisfactory, 3: good, 4: very good)
4. Time spent on spinal anesthesia [min]
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Lateral position with the fracture site up
Since there is no clear difference in the prevalence of proximal femoral fractures (femoral neck fracture, femoral trochanteric fracture). Therefore, performing spinal anesthesia in left lateral position in all cases is able to randomize (the fractured side is naturally randomized up or down).
The method of anesthesia is as follows, which is usually performed in our hospital.
1) After entering the operating room, monitor blood pressure, pulse rate, and percutaneous oxygen saturation in the supine position.
2) While paying attention to the fractured part, take position to left lateral decubitus position by 4-5 staff members.
3) Mark L3/4 (or L2/3, L4/5), disinfect, and apply sterile drape.
4) Using 1% lidocaine, perform local anesthesia at the insertion site with a 25G needle.
5) After inserting a pencil point needle and confirming the backflow of cerebrospinal fluid, administer 3.0 mL of isobaric Bupivacaine (adjusted according to each patient) to subarachnoid space.
Interventions/Control_2
Lateral position with the fracture site down
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
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery for proximal femur fracture at our hospital and meet all of the following three items
1. 20 years old and over
2. Spinal anesthesia is scheduled
3. Obtained written informed consent from the patient or patient's family regarding participation in the study
Key exclusion criteria
Corresponds to any of the following
1. Fractures may dislocate depending on lateral position
2. Atrial fibrillation: Heart rate is difficult to evaluate
3. Taking beta-blocker: Possibility of little fluctuation in heart rate
4. Cannot take the lateral decubitus position
5. No / less pain in the fractured part
(During continuous opioid administration, use of analgesics within 6 hours, hemiplegia on the fracture side, etc.)
6. Patients who are judged to be incompatible by anesthesiologist
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Aidu Chuo Hospital
Division name
Department of Anesthesiology
Zip code
9658611
Address
1-1, Tsuruga-machi, Aizuwakamatsu city, Fukushima, Japan
TEL
0242251515
kei-y7of@fmu.ac.jp
Public contact
Name of contact person
| 1st name | keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Aidu Chuo Hospital
Division name
Department of Anesthesiology
Zip code
9658611
Address
1-1, Tsuruga-machi, Aizuwakamatsu city, Fukushima, Japan
TEL
0242251515
Homepage URL
kei-y7of@fmu.ac.jp
Sponsor or person
Institute
Aidu Chuo Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Aidu Chuo Hospital, Department of Anesthesiology
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
Aidu Chuo Hospital
Address
1-1, Tsuruga-machi, Aizuwakamatsu city, Fukushima, Japan
Tel
0242251515
kanoh@onchikai.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
会津中央病院 手術室
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jaclinicalreports.springeropen.com/articles/10.1186/s40981-023-00595-y
Number of participants that the trial has enrolled
78
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
| 2021 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049892
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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