Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation

July 1, 2015 updated by: Yonsei University
Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the preferred modality of anesthesia. The use of sciatic nerve block has recently gained popularity, however, without the supporting evidence of any benefits. This study was to evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative pain in diabetic foot patients undergoing minor LEA.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

86

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

25 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

consecutive 86 diabetic foot patients who underwent minor LEA

Description

Inclusion Criteria:

  • diabetic foot patients who underwent minor LEA

Exclusion Criteria:

  • emergency cases
  • patients who underwent major upper or lower extremity amputations
  • patients who received general anesthesia following fail regional or spinal anesthesia
  • patients who underwent LEA within 1year, and patients who underwent other concomitant surgeries

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Group A
patients undergo general anesthesia
Group B
spinal anesthesia
Group C
ultrasound-guided sciatic nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean blood pressure
Time Frame: every ten minutes from preinduction to 30minutes after sugery
every ten minutes from preinduction to 30minutes after sugery
Mean blood pressure
Time Frame: from arrival at recovery room until 20miutes after surgery at recovery room
from arrival at recovery room until 20miutes after surgery at recovery room
Heart rate
Time Frame: every ten minutes from preinduction to 30minutes after sugery
every ten minutes from preinduction to 30minutes after sugery
Heart rate
Time Frame: from arrival at recovery room until 20miutes after surgery at recovery room
from arrival at recovery room until 20miutes after surgery at recovery room

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

January 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-1022

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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