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Clinical Trials/NCT04981067
NCT04981067
Active, not recruiting
Not Applicable

Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery

Seoul National University Hospital1 site in 1 country45 target enrollmentAugust 24, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Foot
Sponsor
Seoul National University Hospital
Enrollment
45
Locations
1
Primary Endpoint
Median effective anesthetic concentration 90 (MEAC 90)
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2021
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seokha Yoo

Clinical Assistant Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Median effective anesthetic concentration 90 (MEAC 90)

Time Frame: within 30 minutes from the popliteal sciatic block

Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients

Secondary Outcomes

  • Motor block onset time(within 30 minutes from the popliteal sciatic block)
  • Block duration(within 24 hours post-operatively)
  • Any adverse events(within 24 hours post-operatively)
  • Time to first rescue analgesia(within 24 hours post-operatively)
  • Median effective anesthetic concentration 50 (MEAC 50)(within 30 minutes from the popliteal sciatic block)
  • Sensory block onset time(within 30 minutes from the popliteal sciatic block)

Study Sites (1)

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