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Active, Not Recruiting

NCT Number: NCT04981067

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

Primary outcomes

  1. 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

  1. Median effective anesthetic concentration 50 (MEAC 50)

    Time frame: within 30 minutes from the popliteal sciatic block

    Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients

  2. Sensory block onset time

    Time frame: within 30 minutes from the popliteal sciatic block

    Check for sensory blockade every 5 minutes until 30 minutes after block performed. For sensory block, cold sense using alcohol swabs is evaluated on the foot, comparing with the opposite foot, on a 3-point scale (0 points if there is no cold sense at all, 1 point if there is a decrease, 2 points if it is the same with the opposite foot).

    The time it takes to block to 0 point is the sensory blockade onset time.

  3. Motor block onset time

    Time frame: within 30 minutes from the popliteal sciatic block

    Check for motor blockade every 5 minutes until 30 minutes after block performed. Dorsiflexion and plantar flexion is evaluated, compared to the opposite foot, on a 3-point scale (0 points for inability to move 1 point for reduced movement 2 points for normal movement).

    The time it takes to block to 0 point is the motor blockade onset time.

  4. Block duration

    Time frame: within 24 hours post-operatively

    Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively.

  5. Time to first rescue analgesia

    Time frame: within 24 hours post-operatively

    Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively.

  6. Any adverse events

    Time frame: within 24 hours post-operatively

    Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jul 28, 2021
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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