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The purpose of this study was to determine the minimum effective dose of a local anesthetic for proper anesthesia for popliteal sciatic nerve block under ultrasound guidance in patients undergoing surgery for diabetic foot disease.
Unlike general patients, patients with diabetic foot disease often have diabetic neuropathy and thus have increased sensitivity to local anesthetics. Therefore, when performing sciatic nerve block, it is essential to properly adjust the dose to prevent neurotoxicity and delay in recovery due to local anesthetics.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sciatic nerve block using same or decreased concentration of local anesthetic | Other | 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. |
|
| Sciatic nerve block using increased concentration of local anesthetic | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maintain the concentration of ropivacaine as same as those used in the previous participant | Other | Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment |
| Measure | Description | Time Frame |
|---|---|---|
| Median effective anesthetic concentration 90 (MEAC 90) | Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients | within 30 minutes from the popliteal sciatic block |
| Measure | Description | Time Frame |
|---|---|---|
| Median effective anesthetic concentration 50 (MEAC 50) | Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients | within 30 minutes from the popliteal sciatic block |
| Sensory block onset time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seokha Yoo, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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The biased coin design up-and-down method
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| Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant | Other | 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 | Other | Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant. |
|
Check for sensory blockade every 5 minutes until 30 minutes after block performed. For sensory block, cold sense using alcohol swabs is evaluated on the foot, comparing with the opposite foot, on a 3-point scale (0 points if there is no cold sense at all, 1 point if there is a decrease, 2 points if it is the same with the opposite foot).
The time it takes to block to 0 point is the sensory blockade onset time.
| within 30 minutes from the popliteal sciatic block |
| Motor block onset time | Check for motor blockade every 5 minutes until 30 minutes after block performed. Dorsiflexion and plantar flexion is evaluated, compared to the opposite foot, on a 3-point scale (0 points for inability to move 1 point for reduced movement 2 points for normal movement). The time it takes to block to 0 point is the motor blockade onset time. | within 30 minutes from the popliteal sciatic block |
| Block duration | Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively. | within 24 hours post-operatively |
| Time to first rescue analgesia | Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively. | within 24 hours post-operatively |
| Any adverse events | Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension | within 24 hours post-operatively |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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