Analyzing Anesthetic Techniques in Diabetic Foot Amputation
NCT ID: NCT06552910
Last Updated: 2024-09-05
Study Results
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Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2024-07-01
2024-12-30
Brief Summary
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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.
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Detailed Description
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As neuraxial anesthesia, a type of regional anesthetic, does not require positive mechanical breathing and offers superior pain management, less surgical stress response, and enhanced blood flow, it should theoretically result in a better prognosis than general anesthesia. However, due to the increased incidence of macrovascular complications such as peripheral artery occlusive disease, cerebrovascular disease, and coronary heart disease in patients undergoing diabetic foot amputation, prophylactic or therapeutic anticoagulation is necessary. On the other hand, peripheral nerve block (PNB) shares many theoretical advantages of regional anesthesia and can be beneficial in these cases.
The goal of the research is to assess the outcomes of anesthetic procedures carried out in diabetic foot amputation cases using data from an inpatient database. The hypothesis is that peripheral nerve block will be less likely than general anesthesia to cause postoperative complications. The primary outcome is 30-day mortality following lower extremity amputation; secondary outcomes include composite morbidity from potentially fatal sequelae and hospital discharge duration.
Materials and Methods This study will be conducted using a retrospective chart review method. The study will utilize data from the medical records of patients. Medical data from patients with diabetic foot at Ankara Bilkent City Hospital between 2021 and 2023 will be included in the study. These patients will include those who have toe, ankle, or foot amputations. This research will encompass all individuals who had surgery during this time. Patients with diabetic feet who had their feet, ankles, or toes amputated will meet the inclusion criteria. Exclusion criteria will include those under the age of 18, those whose amputations were performed for reasons other than diabetic foot, and those with insufficient medical data.
Since this study will be conducted retrospectively, the choice of anesthesia method was based on clinical experience.
Using the hospital information management system, patients' medical records will be examined retrospectively. Baseline patient demographic data will include age, sex, height, weight, body mass index, nature of the procedure, smoking status, and American Society of Anesthesiologists physical status classification. Preoperative medication records will be gathered, including beta-blockers, calcium channel blockers, insulin, renin-angiotensin system antagonists, anticoagulant or antiplatelet medicines, and HMG-CoA reductase inhibitors. The patients' comorbidities will also be collected, including the presence of a wound infection, bleeding disorders, sepsis, and whether the surgery was an emergency. Additionally, the history of diabetes, the number of pack-years of smoking, and histories of chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, chronic kidney disease, and steroid dependence will be documented. Preoperative values of hematocrit, hemoglobin, platelets, creatinine, and albumin will be collected, along with details of the type of anesthesia (general, spinal, or epidural), length of surgery, intraoperative blood loss, postoperative pain ratings, and complications.
Major complications will include pneumonia (as defined by the European Perioperative Clinical Outcome guidelines), myocardial infarction (as defined by the World Health Organization), stroke (defined as a central neurologic deficit persisting postoperatively for more than 24 hours), venous thromboembolism (confirmed on imaging), delirium (confirmed by a psychiatrist), acute kidney injury (as defined by the Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, and re-operation. Secondary outcomes and mortality will be the primary outcome measures.
Statistical Analysis Descriptive statistics will be employed to summarize the demographic and clinical characteristics of the patients. The association between the type of anesthesia used and postoperative outcomes will be analyzed using the Chi-square test for categorical variables and the Student's t-test for continuous variables. Kaplan-Meier survival analysis will be conducted to estimate survival rates and compare durations of hospital stays between patients receiving different types of anesthesia. Logistic regression will be used to adjust for potential confounders and assess the impact of anesthetic techniques on postoperative complications. Results will be considered statistically significant at a p-value of less than 0.05. All statistical analyses will be performed using the hospital information management system.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Group/Cohort 1
Label: Peripheral Nerve Block Description: Injection of anesthetic near specific nerves to block sensation in a particular area of the body.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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semih başkan
Associate Professor
Principal Investigators
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Semih Başkan
Role: STUDY_DIRECTOR
Ankara City Hospital Bilkent
Locations
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Semih Başkan
Etimesgut, Ankara, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Primadhi RA, Septrina R, Hapsari P, Kusumawati M. Amputation in diabetic foot ulcer: A treatment dilemma. World J Orthop. 2023 May 18;14(5):312-318. doi: 10.5312/wjo.v14.i5.312. eCollection 2023 May 18.
Zhu G, Xu J, Dai H, Min D, Guo G. Effect of peripheral nerve block versus general anesthesia on the hemodynamics and prognosis of diabetic patients undergoing diabetic foot Surgery. Diabetol Metab Syndr. 2023 Oct 26;15(1):213. doi: 10.1186/s13098-023-01185-9.
Kim HJ, Park CG, Choi YS, Lee YS, Kwak HJ. Effects of Anesthetic Techniques on the Risk of Postoperative Complications Following Lower Extremity Amputation in Diabetes Patients with Coagulation Abnormalities: A Retrospective Cohort Study Using Propensity Score Analysis. J Clin Med. 2021 Nov 28;10(23):5598. doi: 10.3390/jcm10235598.
Other Identifiers
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SMH1
Identifier Type: -
Identifier Source: org_study_id
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