Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Primary Purpose
Diabetic Foot, Diabetic Neuropathies
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Maintain the concentration of ropivacaine as same as those used in the previous participant
Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Sciatic nerve block using same or decreased concentration of local anesthetic
Sciatic nerve block using increased concentration of local anesthetic
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Median effective anesthetic concentration 90 (MEAC 90)
Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients
Secondary Outcome Measures
Median effective anesthetic concentration 50 (MEAC 50)
Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients
Sensory block onset time
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.
Motor block onset time
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.
Block duration
Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively.
Time to first rescue analgesia
Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively.
Any adverse events
Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension
Full Information
NCT ID
NCT04981067
First Posted
June 28, 2021
Last Updated
October 24, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04981067
Brief Title
Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Official Title
Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Diabetic Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The biased coin design up-and-down method
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sciatic nerve block using same or decreased concentration of local anesthetic
Arm Type
Other
Arm Description
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.
Arm Title
Sciatic nerve block using increased concentration of local anesthetic
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Maintain the concentration of ropivacaine as same as those used in the previous participant
Intervention Description
Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment
Intervention Type
Other
Intervention Name(s)
Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Intervention Description
Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment
Intervention Type
Other
Intervention Name(s)
Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Intervention Description
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.
Primary Outcome Measure Information:
Title
Median effective anesthetic concentration 90 (MEAC 90)
Description
Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients
Time Frame
within 30 minutes from the popliteal sciatic block
Secondary Outcome Measure Information:
Title
Median effective anesthetic concentration 50 (MEAC 50)
Description
Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients
Time Frame
within 30 minutes from the popliteal sciatic block
Title
Sensory block onset time
Description
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.
Time Frame
within 30 minutes from the popliteal sciatic block
Title
Motor block onset time
Description
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.
Time Frame
within 30 minutes from the popliteal sciatic block
Title
Block duration
Description
Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively.
Time Frame
within 24 hours post-operatively
Title
Time to first rescue analgesia
Description
Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively.
Time Frame
within 24 hours post-operatively
Title
Any adverse events
Description
Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension
Time Frame
within 24 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngwon Kim, MD
Phone
+82-2-2072-3283
Email
youngwon.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seokha Yoo, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngwon Kim, MD
Phone
02-2072-3283
Email
youngwon.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Seokha Yoo, MD
Phone
02-2072-3283
Email
muroki22@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
We'll reach out to this number within 24 hrs