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

NCT04981067 | Active Not Recruiting DMC

• 1 other identifier: 2102-120-1220
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Neuropathies

Outcome Measures

Primary Outcomes (1)

• Median effective anesthetic concentration 90 (MEAC 90)

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

  within 30 minutes from the popliteal sciatic block

Secondary Outcomes (6)

• 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

• Motor block onset time

  within 30 minutes from the popliteal sciatic block

• Block duration

  within 24 hours post-operatively

• Time to first rescue analgesia

  within 24 hours post-operatively

Study Arms (2)

Sciatic nerve block using same or decreased concentration of local anesthetic

OTHER

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.

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

Sciatic nerve block using increased concentration of local anesthetic

OTHER

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.

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

Interventions

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

Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment

Sciatic nerve block using same or decreased concentration of local anesthetic

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

Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment

Sciatic nerve block using same or decreased concentration of local anesthetic

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

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

Sciatic nerve block using increased concentration of local anesthetic

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetic Neuropathies

Interventions

S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Seokha Yoo, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The biased coin design up-and-down method

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 28, 2021
• Study Start: August 24, 2021
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

KR (1)