UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026748 |
|---|---|
| Receipt number | R000029119 |
| Scientific Title | Ultrasound-guided lateral approach for sciatic nerve block: a comparison with the anterior approach |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2017/11/10 15:51:02 |
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Basic information
Public title
Ultrasound-guided lateral approach for sciatic nerve block: a comparison with the anterior approach
Acronym
Ultrasound-guided lateral approach for sciatic nerve block
Scientific Title
Ultrasound-guided lateral approach for sciatic nerve block: a comparison with the anterior approach
Scientific Title:Acronym
Ultrasound-guided lateral approach for sciatic nerve block
Region
| Japan |
Condition
Condition
Disease on distal to the knee requiring orthopedic surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of posterior femoral cutaneous nerve block by different approaches of sciatic nerve block
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of posterior femoral cutaneous nerve block at 30 min after execution of a sciatic nerve block
Key secondary outcomes
1. Incidence of sensory block by a sciatic nerve block within 30 min after execution of a sciatic nerve block
2. Incidence of motor block by a sciatic nerve block within 30 min after execution of a sciatic nerve block
3. Time required to identify the sciatic nerve under ultrasound
4. Distance from the skin to the sciatic nerve
5. Needle distance under the skin when the tip of the needle reaching the sciatic nerve
6. Time required to perform a sciatic nerve block
7. Incidence of adverse effects caused by a sciatic nerve block
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To perform a sciatic nerve block using the anterior approach
Interventions/Control_2
To perform a sciatic nerve block using the lateral 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing a unilateral lower extremity surgery on distal to the knee under general anesthesia combined with peripheral nerve blocks
2. American Society of Anesthesiologists PS 1-3
3. Written informed consent is provided
Key exclusion criteria
1. Inability to communicate lucidly
2. Infection at the injection site
3. Prior surgery on the ipsilateral hip or femur
4. BMI > 35 kg/m2
5. BW < 40 kg
6. Allergy to local anesthetics
7. Pre-existing sensory disturbance of the ipsilateral lower extremity
8. Patients who are regarded ineligible by researchers with any other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Kansai Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-3-1, Shin-machi, Hirakata-city, Osaka, Japan
TEL
+81-72-804-0101
ytaka@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshida |
Organization
Kansai Medical University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-3-1, Shin-machi, Hirakata-city, Osaka, Japan
TEL
+81-72-804-0101
Homepage URL
ytaka@mac.com
Sponsor or person
Institute
Department of Anesthesiology, Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kansai Medical University Hospital
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
Address
Tel
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 | 03 | 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
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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029119
