Analyzing Anesthetic Techniques in Diabetic Foot Amputation

NCT06552910 | Recruiting

• 1 other identifier: SMH1
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic Foot; Nerve Block; Diabetes Complications; Amputation, Surgical

Outcome Measures

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: 30 days post-surgery.

Secondary Outcomes (2)

• Composite Morbidity from Potentially Fatal Sequelae

  From the date of surgery until hospital discharge, assessed up to 3 months.

• Hospital Discharge Duration

  From the date of surgery until hospital discharge, assessed up to 3 months.

Study Arms (1)

Group/Cohort 1

Label: Peripheral Nerve Block Description: Injection of anesthetic near specific nerves to block sensation in a particular area of the body.

Procedure: Nerve Block

Interventions

Nerve Block PROCEDURE

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.

Group/Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Patients diagnosed with diabetic foot requiring amputation. Patients who underwent toe, ankle, or foot amputation. Patients aged 18 years or older.

You may not qualify if:

• Patients under the age of 18. Amputations performed for reasons other than diabetic foot. Patients with incomplete or insufficient medical records.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Semih Başkan

Etimesgut, Ankara, 06790, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 37304194 RESULT

• 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.

  PMID: 37880794 RESULT

• 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.

  PMID: 34884298 RESULT

MeSH Terms

Conditions

Diabetic Foot; Diabetes Complications

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Semih Başkan

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Central Study Contacts

Semih Başkan, MD

CONTACT

+905326030675; drsemkan@gmail.com

Semih Başkan

CONTACT

+95326030675; drsemkan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 14, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)