A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study

• Conditions: Daibetic Foot

• Registration Number: NCT05012059
• Lead Sponsor: Yonsei University

Brief Summary

Retrospective data collection. The aim of this study is to compare general anesthesia and nerve block anesthesia with respect to the postoperative complications in patients undergoing diabetic leg amputation and having bleeding tendency.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-19
• Last Update Posted: 2021-08-19
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Adults patients ≥20 years who underwent lower extremity amputation for diabetic foot under general anesthesia or PNB and having coagulopathy in which condition that neuraxial block is contraindicated

Exclusion Criteria

1. patients with prior surgical history within 1 month
2. combined operation (joint operation)
3. patients who required continuous intravenous administration of vasopressors and/or mechanical ventilation prior to surgery
4. combination of general anesthesia and PNB

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of major complication	Within 1 month after the surgery	Major complications included pneumonia (followed the definition of European Perioperative Clinical Outcome), myocardial infarction (followed the definition of World Health Organization), stroke (A central neurologic deficit persisting postoperatively for \> 24 h), venous thromboembolism (confirmed by image study), delirium (confirmed by psychiatrist), acute kidney injury (based on Kidney Disease: Improving Global Outcomes Criteria), new requirement for dialysis, surgical site infection, Return to the OP room.
Occurrence of mortality	Within 1 month after the surgery	Mortality refers all deaths.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of