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

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ClinicalTrials.gov Identifier: NCT04981067
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Seokha Yoo, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Diabetic Neuropathies 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 Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The biased coin design up-and-down method
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Actual Study Start Date : August 24, 2021
Estimated Primary Completion Date : January 11, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sciatic nerve block using same or decreased concentration of local anesthetic
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
Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment

Other: Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
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 increased concentration of local anesthetic
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
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Infection of the popliteal region
  2. Severe coagulation abnormality
  3. Allergic reaction or hypersensitivity to local anesthetics
  4. Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
  5. When it is impossible to evaluate sensory blockage and motor blockage
  6. When the patient refuses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981067


Contacts
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Contact: Youngwon Kim, MD +82-2-2072-3283 youngwon.md@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Youngwon Kim, MD    02-2072-3283    youngwon.md@gmail.com   
Contact: Seokha Yoo, MD    02-2072-3283    muroki22@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Seokha Yoo, MD Seoul National University Hospital
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Responsible Party: Seokha Yoo, Clinical Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04981067    
Other Study ID Numbers: 2102-120-1220
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents