Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
NCT ID: NCT04981067
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
45 participants
INTERVENTIONAL
2021-08-24
2026-12-31
Brief Summary
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Detailed Description
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If the appropriate effective dose of local anesthetic for sciatic nerve block is found in patients with diabetic foot through this study, it is expected that it will be a useful basis for establishing a safe anesthetic method in the case of diabetic foot surgery.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Sciatic nerve block using same or decreased concentration of local anesthetic
If the sciatic nerve block in the previous participant was successful, the concentration of local anesthetic would be maintained or decreased 0.05% in the next patient based on a random assignment.
Maintain the concentration of ropivacaine as same as those used in the previous participant
Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment
Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment
Sciatic nerve block using increased concentration of local anesthetic
If the sciatic nerve block in the previous participant was not successful, the concentration of local anesthetic would be increased 0.05% in the next patient.
Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.
Interventions
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Maintain the concentration of ropivacaine as same as those used in the previous participant
Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment
Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment
Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Severe coagulation abnormality
3. Allergic reaction or hypersensitivity to local anesthetics
4. Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
5. When it is impossible to evaluate sensory blockage and motor blockage
6. When the patient refuses
19 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seokha Yoo
Clinical Assistant Professor
Principal Investigators
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Seokha Yoo, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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2102-120-1220
Identifier Type: -
Identifier Source: org_study_id