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Active Not RecruitingNCT04981067

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
45 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMaintain the concentration of ropivacaine as same as those used in the previous participantMaintain 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 participantDecrease 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 participantIncrease ropivacaine concentration by 0.05% from the concentration used in the previous participant.

Timeline

Start date
2021-08-24
Primary completion
2026-12-28
Completion
2026-12-31
First posted
2021-07-28
Last updated
2024-11-29

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04981067. Inclusion in this directory is not an endorsement.