Analyzing Anesthetic Techniques in Diabetic Foot Amputation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Study Population Description The study population consisted of patients diagnosed with diabetic foot who required amputation and were treated at Ankara Bilkent City Hospital between 2021 and 2023. The population included adults aged 18 years and older, irrespective of sex. This cohort was selected through a retrospective chart review method, ensuring comprehensive inclusion of all eligible patients who underwent toe, ankle, or foot amputations due to diabetic foot during the specified period. The primary focus was on evaluating the outcomes associated with different anesthetic techniques used during these procedures. Sampling Method: Non-Probability Sample Minimum Age: 18 Years Maximum Age: Not applicable Sex: All Gender-Based: No Accepts Healthy Volunteers: No
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Nerve Block
Procedure/SurgerySince 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.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Group/Cohort 11 intervention
Trial outcomes
Primary outcomes
1
30-Day Mortality Rate in Patients Undergoing Diabetic Foot Amputation
This study aims to evaluate the 30-day mortality rate in patients undergoing diabetic foot amputation. Mortality rate is defined as the occurrence of death within 30 days following surgery. The primary focus is to compare the short-term survival effects of different anesthesia techniques (general anesthesia and peripheral nerve block) on these patients.
Time frame
Time Frame: 30 days post-surgery.Secondary outcomes
1
Composite Morbidity from Potentially Fatal Sequelae
This secondary outcome measure evaluates the occurrence of composite morbidity resulting from potentially fatal sequelae in patients undergoing diabetic foot amputation. This includes major complications such as pneumonia, myocardial infarction, stroke, venous thromboembolism, delirium, acute kidney injury, new requirement for dialysis, surgical site infection, and re-operation. The aim is to assess how different anesthesia techniques impact the rate and severity of these complications.
Time frame
From the date of surgery until hospital discharge, assessed up to 3 months.2
Hospital Discharge Duration
This secondary outcome measure focuses on the length of hospital stay following diabetic foot amputation. It aims to determine whether the type of anesthesia used (general anesthesia or peripheral nerve block) influences the duration of hospitalization, thereby providing insights into recovery times and healthcare resource utilization.
Time frame
From the date of surgery until hospital discharge, assessed up to 3 months.Sponsors and contacts
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Source ClinicalTrials.gov