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Analyzing Anesthetic Techniques in Diabetic Foot Amputation

NCT06552910 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-09-05

No results posted yet for this study

Summary

Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes

Introduction:

Diabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. The study aims to evaluate the outcomes of different anesthetic techniques in diabetic foot amputation, specifically comparing peripheral nerve block (PNB) and general anesthesia.

Objective:

To assess the impact of anesthetic procedures on outcomes in diabetic foot amputation cases using inpatient data. The hypothesis is that PNB will result in fewer postoperative complications than general anesthesia-primary outcome: 30-day mortality; secondary outcomes: composite morbidity and hospital discharge duration.

Materials and Methods:

This retrospective chart review will analyze medical records of patients with diabetic foot at Ankara Bilkent City Hospital from 2021 to 2023. Inclusion criteria: patients who underwent toe, ankle, or foot amputations. Exclusion criteria: patients under 18, amputations for non-diabetic reasons, and insufficient medical data. Data will include patient demographics, preoperative medications, comorbidities, and surgical details. Major complications, secondary outcomes, and mortality will be primary measures.

Statistical Analysis:

Descriptive statistics will summarize patient characteristics. Chi-square and Student t-tests will analyze associations between anesthesia type and postoperative outcomes. Kaplan-Meier survival analysis will compare hospital stay durations. Logistic regression will adjust for confounders and assess the impact of anesthetics on complications. Results will be significant at p \< 0.05.

Conditions

  • Diabetic Foot
  • Amputation, Surgical

Interventions

PROCEDURE

Nerve Block

Since this study was conducted retrospectively, the choice of anesthesia method was made based on our own experience. For every patient undergoing LEA under PNB, a popliteal sciatic nerve block was carried out. A saphenous nerve block was also carried out if the procedure was on a level that was close to the metatarsal bone. In some circumstances (distal surgery, such as the metatarsal bone), a sensory block on the surgical site was tried following the popliteal sciatic nerve block to demonstrate that the saphenous nerve's anatomic abnormalities required an additional saphenous nerve block. The related block was later carried out, if needed. Under ultrasound guidance, every PNB was finished.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Principal Investigators

  • Semih Başkan · Ankara City Hospital Bilkent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-01
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552910 on ClinicalTrials.gov