Effects of Ankle Block on Postoperative Analgesia in Diabetic and Non-Diabetic Patients

NCT07404124 | Not Yet Recruiting

• 1 other identifier: FSM-SUAM-ANKLEBLOCK-2026
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus; Diabetic Neuropathy; Postoperative Pain Management

Keywords

Ankle Block; Ultrasound-Guided Regional Anesthesia; Peripheral Nerve Block; Diabetes Mellitus; Diabetic Neuropathy; Glycemic Control; Postoperative Analgesia; HBA1C; Lower Extremity Surgery; Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• 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).

  From block completion up to 30 minutes after block administration

Secondary Outcomes (3)

• Motor Block Onset Time

  From block completion up to 30 minutes after block administration

• Total Opioid Consumption in the First 24 Hours

  First 24 hours after surgery

• Postoperative Pain Scores

  At 6, 12, and 24 hours after surgery

Study Arms (1)

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.

Procedure: Ultrasound-Guided Ankle Block

Interventions

Ultrasound-Guided Ankle Block PROCEDURE

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

Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• doga meric yukselen, MD

  ISTANBUL PROVINCIAL HEALTH DIRECTORATE FATIH SULTAN MEHMET TRAINING AND RESEARCH HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DOGA MERİC YUKSELEN, MD

CONTACT

+905362963155; d.m.boybeyi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Specialist

Model Details: This is a single-center, prospective observational study with no intervention assignment.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-01

Locations

TU (1)