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

August 17, 2021 updated by: Yonsei University
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-749
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of major complication
Time Frame: 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.
Within 1 month after the surgery
Occurrence of mortality
Time Frame: Within 1 month after the surgery
Mortality refers all deaths.
Within 1 month after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (ACTUAL)

August 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-0378

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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