Diabetic FootNCT04981067
Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
A study testing 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 and Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant in people with Diabetic Foot and Diabetic Neuropathies, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Diabetic Foot, Diabetic Neuropathies
- What is being tested?
- 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 and Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2021to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Median Effective Concentration of Ropivacaine for Ultrasound-guided 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.
Read the 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
- Diabetic Foot, Diabetic Neuropathies
- Being tested
- 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
- Medical subject headings
- Diabetic Foot, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintain the concentration of ropivacaine as same as those used in the previous participantOther
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 participantOther
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 participantOther
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median effective anesthetic concentration 90 (MEAC 90)
Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients
Measured: within 30 minutes from the popliteal sciatic block
Secondary outcomes (6)
Median effective anesthetic concentration 50 (MEAC 50)
Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients
Measured: within 30 minutes from the popliteal sciatic block
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.
Measured: within 30 minutes from the popliteal sciatic block
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.
Measured: within 30 minutes from the popliteal sciatic block
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.
Measured: within 24 hours 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.
Measured: within 24 hours post-operatively
Any adverse events
Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension
Measured: within 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start24 Aug 2021
- Primary completion28 Dec 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The biased coin design up-and-down method
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seokha Yoo, Seoul National University Hospital
- Investigators
- Seokha Yoo, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981067
- Sponsor's protocol ID
- 2102-120-1220
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
- ClinicalTrials.gov ID
- NCT04981067
- Acronym / sponsor ID
- 2102-120-1220
- Conditions
- Diabetic Foot, Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The biased coin design up-and-down method
| Arm | Type | Receives |
|---|---|---|
| Sciatic nerve block using same or decreased concentration of local anesthetic | Other | 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 participantIf 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. |
| Sciatic nerve block using increased concentration of local anesthetic | Other | Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participantIf 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintain 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 | Other | 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 participantDecrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment | Other | 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 participantIncrease ropivacaine concentration by 0.05% from the concentration used in the previous participant. | Other | Sciatic nerve block using increased concentration of local anesthetic |
Primary outcome
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
6 secondary outcomes
Median effective anesthetic concentration 50 (MEAC 50)
Time frame: within 30 minutes from the popliteal sciatic block
Sensory block onset time
Time frame: within 30 minutes from the popliteal sciatic block
Motor block onset time
Time frame: within 30 minutes from the popliteal sciatic block
Block duration
Time frame: within 24 hours post-operatively
Time to first rescue analgesia
Time frame: within 24 hours post-operatively
Any adverse events
Time frame: within 24 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seokha Yoo, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant in people with Diabetic Foot and Diabetic Neuropathies, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median effective anesthetic concentration 90 (MEAC 90) (time frame: within 30 minutes from the popliteal sciatic block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.