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

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    45
  • sponsor
    Seoul National University Hospital
Updated on 24 March 2022
anesthesia
diabetic foot
anaesthetic

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.

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.

Details
Condition Diabetic Foot, Diabetic Neuropathies
Treatment Maintain the concentration of ropivacaine as same as those used in the previous participant, Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant, Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Clinical Study IdentifierNCT04981067
SponsorSeoul National University Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease

Exclusion Criteria

Infection of the popliteal region
Severe coagulation abnormality
Allergic reaction or hypersensitivity to local anesthetics
Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
When it is impossible to evaluate sensory blockage and motor blockage
When the patient refuses
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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