Clincosm LogoSign in Get a demo

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

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05012059
Collaborator
(none)
300
Enrollment
1
Location
2
Anticipated Duration (Months)
149.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Comparison of General Versus Peripheral Nerve Block for Lower Extremity Amputation in Diabetic Patients With Bleeding Tendency: a Retrospective Study
    Anticipated Study Start Date :
    Aug 1, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2021
    Anticipated Study Completion Date :
    Oct 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Occurrence of mortality [Within 1 month after the surgery]

      Mortality refers all deaths.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul Korea, Republic of 120-749

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Hye Jin Kim, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05012059
    Other Study ID Numbers:
    • 4-2021-0378
    First Posted:
    Aug 19, 2021
    Last Update Posted:
    Aug 19, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemostatic Disorders
    Blood Coagulation Disorders

    Study Results

    No Results Posted as of Aug 19, 2021