Diabetes MellitusANKLE-DMNCT07404124
Effects of Ankle Block on Postoperative Analgesia in Diabetic and Non-Diabetic Patients
A study testing Ultrasound-Guided Ankle Block in people with Diabetes Mellitus and Diabetic Neuropathy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the effects of ultrasound-guided ankle block on sensory and motor block characteristics and postoperative analgesic outcomes in patients undergoing lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Neuropathy, Postoperative Pain Management
- What is being tested?
- Ultrasound-Guided Ankle Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Nov 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Patients scheduled for lower extremity surgery under ultrasound-guided ankle block as part of routine clinical care.
- Patients able to provide written informed consent.
- Availability of complete perioperative data including blood glucose levels, -HbA1c values, pain scores, and postoperative analgesic consumption.
Who cannot join
- Refusal or inability to provide informed consent.
- Failure of ankle block requiring conversion to another anesthesia technique.
- Known coagulation disorders contraindicating peripheral nerve block.
- Active infection at the site of block application.
- Chronic opioid or analgesic use, chronic alcohol use, or substance abuse.
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
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- Severe renal or hepatic insufficiency.
- Known allergy to local anesthetics such as lidocaine or bupivacaine.
- Inability to perform perioperative blood glucose monitoring.
- Cognitive impairment or psychiatric conditions interfering with study participation or data collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul
doga meric yukselen, MD, +90 536 296 31 55, d.m.boybeyi@gmail.com
About this study
Official title: Comparison of Sensory and Motor Block Characteristics and Postoperative Analgesic Consumption After Ultrasound-Guided Ankle Block in Diabetic and Non-Diabetic Patients Undergoing Lower Extremity Surgery
This prospective observational study aims to evaluate the effects of ultrasound-guided ankle block on sensory and motor block characteristics and postoperative analgesic outcomes in patients undergoing lower extremity surgery. The study will compare diabetic and non-diabetic patients and will also assess the impact of glycemic control on block onset time and postoperative analgesic consumption.
Ankle block is commonly used in patients undergoing foot and ankle surgery, particularly in those with diabetes, peripheral neuropathy, or vascular disease, when general or neuraxial anesthesia may not be suitable. Previous studies suggest that diabetic neuropathy and impaired glycemic control may influence the onset and duration of peripheral nerve blocks.
Read more
Adult patients scheduled for lower extremity surgery under ankle block will be included. All procedures will be performed as part of routine clinical care, and no additional interventions will be applied for research purposes. Sensory and motor block onset times, postoperative pain scores, opioid consumption within the first 24 hours, and patient and surgeon satisfaction will be recorded.
The results of this study are expected to provide clinically relevant information regarding the effects of diabetes and glycemic control on ankle block characteristics and postoperative analgesia.
Read the detailed description
Diabetes mellitus is a common chronic metabolic disease, and its increasing prevalence has led to a rise in diabetes-related complications. Diabetic neuropathy is one of the most frequent complications and is associated with structural and functional changes in peripheral nerves, including axonal degeneration and demyelination. These alterations may affect the onset, duration, and quality of peripheral nerve blocks.
Previous clinical and experimental studies have demonstrated that peripheral nerve blocks in patients with diabetic neuropathy may have longer duration and altered onset times compared to non-diabetic patients. Proposed mechanisms include changes in sodium and potassium channel function, delayed clearance of local anesthetics, and reduced microvascular absorption due to diabetic microangiopathy.
Ultrasound-guided ankle block is a commonly used regional anesthesia technique for foot and ankle surgeries, particularly in patients with diabetic foot ulcers, wound debridement, or minor amputations. It provides effective anesthesia and postoperative analgesia while avoiding the potential risks of general or neuraxial anesthesia in high-risk patients.
This study is designed as a single-center, prospective, observational study conducted at Fatih Sultan Mehmet Training and Research Hospital. Adult patients scheduled for lower extremity surgery under ultrasound-guided ankle block between January 2026 and October 2026 will be included after obtaining written informed consent. No additional interventions beyond routine clinical practice will be performed.
The ankle block will be administered preoperatively under ultrasound guidance by an experienced anesthesiologist using a standardized local anesthetic mixture. Sensory and motor block assessments will be performed using pinprick testing and motor function evaluation. Block onset times and block resolution times will be recorded.
Postoperative outcomes will include pain scores assessed using the Visual Analog Scale (VAS), total opioid consumption within the first 24 hours (expressed as morphine equivalents), time to first analgesic request, and the need for rescue analgesia. Patient and surgeon satisfaction will be evaluated using a 10-point numerical rating scale.
Patients will be categorized based on diabetes status and further subgrouped according to glycemic control using HbA1c levels (<7.5% and ≥7.5%). Outcomes will be compared between diabetic and non-diabetic patients and between glycemic control subgroups to evaluate the effect of diabetes and metabolic control on ankle block characteristics and postoperative analgesic outcomes.
The findings of this study are expected to contribute to a better understanding of regional anesthesia outcomes in diabetic patients and may help optimize anesthetic management strategies in this high-risk population.
- Being tested
- Ultrasound-Guided Ankle Block
- Keywords
- Ankle Block, Ultrasound-Guided Regional Anesthesia, Peripheral Nerve Block, Diabetes Mellitus, Diabetic Neuropathy, Glycemic Control, Postoperative Analgesia, HBA1C, Lower Extremity Surgery, Opioid Consumption
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Ankle BlockProcedure or surgery
Ultrasound-guided ankle block performed as part of routine clinical practice for anesthesia and postoperative analgesia. The procedure is not administered as an experimental intervention and is not assigned by the study protocol
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | Experimental | Adult patients undergoing lower extremity surgery under routine ultrasound-guided ankle block as part of standard clinical care. Participants are not assigned to any intervention for research purposes. Receives: Procedure: Ultrasound-Guided Ankle Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Block Onset Time
Time from completion of ultrasound-guided ankle block to the onset of sensory block, assessed using pinprick testing (score 0: no sensation, 1: reduced sensation, 2: normal sensation).
Measured: From block completion up to 30 minutes after block administration
Secondary outcomes (3)
Motor Block Onset Time
Time from completion of ankle block to onset of motor block, assessed by ankle dorsiflexion and plantarflexion strength, measured in minutes.
Measured: From block completion up to 30 minutes after block administration
Total Opioid Consumption in the First 24 Hours
Total amount of opioid analgesics consumed within the first 24 hours postoperatively, calculated as intravenous morphine equivalents in milligrams.
Measured: First 24 hours after surgery
Postoperative Pain Scores
Postoperative pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. Higher scores indicate worse outcome.
Measured: At 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, prospective observational study with no intervention assignment.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dogameric, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- doga meric yukselen, MD, Principal investigator, ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404124
- Sponsor's protocol ID
- FSM-SUAM-ANKLEBLOCK-2026
- Acronym
- ANKLE-DM
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sensory and Motor Block Characteristics and Postoperative Analgesic Consumption After Ultrasound-Guided Ankle Block in Diabetic and Non-Diabetic Patients Undergoing Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT07404124
- Acronym / sponsor ID
- ANKLE-DM / FSM-SUAM-ANKLEBLOCK-2026
- Keywords
- Ankle Block, Ultrasound-Guided Regional Anesthesia, Peripheral Nerve Block, Diabetes Mellitus, Diabetic Neuropathy, Glycemic Control, Postoperative Analgesia, HBA1C
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
This prospective observational study aims to evaluate the effects of ultrasound-guided ankle block on sensory and motor block characteristics and postoperative analgesic outcomes in patients undergoing lower extremity surgery. The study will compare diabetic and non-diabetic patients and will also assess the impact of glycemic control on block onset time and postoperative analgesic consumption.
Ankle block is commonly used in patients undergoing foot and ankle surgery, particularly in those with diabetes, peripheral neuropathy, or vascular disease, when general or neuraxial anesthesia may not be suitable. Previous studies suggest that diabetic neuropathy and impaired glycemic control may influence the onset and duration of peripheral nerve blocks.
Adult patients scheduled for lower extremity surgery under ankle block will be included. All procedures will be performed as part of routine clinical care, and no additional interventions will be applied for research purposes. Sensory and motor block onset times, postoperative pain scores, opioid consumption within the first 24 hours, and patient and surgeon satisfaction will be recorded.
The results of this study are expected to provide clinically relevant information regarding the effects of diabetes and glycemic control on ankle block characteristics and postoperative analgesia.
Detailed description
Diabetes mellitus is a common chronic metabolic disease, and its increasing prevalence has led to a rise in diabetes-related complications. Diabetic neuropathy is one of the most frequent complications and is associated with structural and functional changes in peripheral nerves, including axonal degeneration and demyelination. These alterations may affect the onset, duration, and quality of peripheral nerve blocks.
Previous clinical and experimental studies have demonstrated that peripheral nerve blocks in patients with diabetic neuropathy may have longer duration and altered onset times compared to non-diabetic patients. Proposed mechanisms include changes in sodium and potassium channel function, delayed clearance of local anesthetics, and reduced microvascular absorption due to diabetic microangiopathy.
Ultrasound-guided ankle block is a commonly used regional anesthesia technique for foot and ankle surgeries, particularly in patients with diabetic foot ulcers, wound debridement, or minor amputations. It provides effective anesthesia and postoperative analgesia while avoiding the potential risks of general or neuraxial anesthesia in high-risk patients.
This study is designed as a single-center, prospective, observational study conducted at Fatih Sultan Mehmet Training and Research Hospital. Adult patients scheduled for lower extremity surgery under ultrasound-guided ankle block between January 2026 and October 2026 will be included after obtaining written informed consent. No additional interventions beyond routine clinical practice will be performed.
The ankle block will be administered preoperatively under ultrasound guidance by an experienced anesthesiologist using a standardized local anesthetic mixture. Sensory and motor block assessments will be performed using pinprick testing and motor function evaluation. Block onset times and block resolution times will be recorded.
Postoperative outcomes will include pain scores assessed using the Visual Analog Scale (VAS), total opioid consumption within the first 24 hours (expressed as morphine equivalents), time to first analgesic request, and the need for rescue analgesia. Patient and surgeon satisfaction will be evaluated using a 10-point numerical rating scale.
Patients will be categorized based on diabetes status and further subgrouped according to glycemic control using HbA1c levels (<7.5% and ≥7.5%). Outcomes will be compared between diabetic and non-diabetic patients and between glycemic control subgroups to evaluate the effect of diabetes and metabolic control on ankle block characteristics and postoperative analgesic outcomes.
The findings of this study are expected to contribute to a better understanding of regional anesthesia outcomes in diabetic patients and may help optimize anesthetic management strategies in this high-risk population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, prospective observational study with no intervention assignment.
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | Experimental | Procedure: Ultrasound-Guided Ankle BlockAdult patients undergoing lower extremity surgery under routine ultrasound-guided ankle block as part of standard clinical care. Participants are not assigned to any intervention for research purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older.
- Patients scheduled for lower extremity surgery under ultrasound-guided ankle block as part of routine clinical care.
- Patients able to provide written informed consent.
- Availability of complete perioperative data including blood glucose levels, -HbA1c values, pain scores, and postoperative analgesic consumption.
Key exclusion criteria (10 listed)
- Refusal or inability to provide informed consent.
- Failure of ankle block requiring conversion to another anesthesia technique.
- Known coagulation disorders contraindicating peripheral nerve block.
- Active infection at the site of block application.
- Chronic opioid or analgesic use, chronic alcohol use, or substance abuse.
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 |
|---|---|---|
| Ultrasound-Guided Ankle BlockUltrasound-guided ankle block performed as part of routine clinical practice for anesthesia and postoperative analgesia. The procedure is not administered as an experimental intervention and is not assigned by the study protocol | Procedure or surgery | Observational Cohort |
Primary outcome
Sensory Block Onset Time
Time frame: From block completion up to 30 minutes after block administration
Time from completion of ultrasound-guided ankle block to the onset of sensory block, assessed using pinprick testing (score 0: no sensation, 1: reduced sensation, 2: normal sensation).
3 secondary outcomes
Motor Block Onset Time
Time frame: From block completion up to 30 minutes after block administration
Total Opioid Consumption in the First 24 Hours
Time frame: First 24 hours after surgery
Postoperative Pain Scores
Time frame: At 6, 12, and 24 hours after surgery
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 11 Feb 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.
doga meric yukselen, MD principal investigator
ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH 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 Ultrasound-Guided Ankle Block in people with Diabetes Mellitus and Diabetic Neuropathy, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 11 Feb 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 Turkey (Türkiye). 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?
Contact DOGA MERİC YUKSELEN, MD (+905362963155, d.m.boybeyi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory Block Onset Time (time frame: From block completion up to 30 minutes after block administration). 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 11 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.