Diabetic Foot, Diabetic Neuropathies
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERMaintain 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
OTHERDecrease 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
OTHERIncrease 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The biased coin design up-and-down method
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease
Exclusion criteria
1. Infection of the popliteal region 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median effective anesthetic concentration 90 (MEAC 90) | within 30 minutes from the popliteal sciatic block | Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median effective anesthetic concentration 50 (MEAC 50) | within 30 minutes from the popliteal sciatic block | Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients |
| Sensory block onset time | within 30 minutes from the popliteal sciatic block | 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. |
| Motor block onset time | within 30 minutes from the popliteal sciatic block | 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. |
| Block duration | within 24 hours post-operatively | Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively. |
| Time to first rescue analgesia | within 24 hours post-operatively | Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively. |
| Any adverse events | within 24 hours post-operatively | Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeokha Yoo, MD
Seoul National University Hospital
Outcome results
None listed