Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery

Seoul National University

Status: Active, not recruiting

Conditions: Diabetic Foot; Diabetic Neuropathies

Treatments: Other: Maintain the concentration of ropivacaine as same as those used in the previous participant; Other: Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant; Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant

Study type: Interventional

Funder types: Other

Identifiers

NCT04981067

2102-120-1220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Sciatic nerve block using same or decreased concentration of local anesthetic

Other group

Description:

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.

Treatment:

Other: Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant

Other: Maintain the concentration of ropivacaine as same as those used in the previous participant

Sciatic nerve block using increased concentration of local anesthetic

Other group

Description:

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.

Treatment:

Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant