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

Diabetic Foot Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440282
• Other study ID #: 4-2014-1022
• Status: Completed
• Phase: N/A
• First received: April 24, 2015
• Last updated: July 1, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 29 Years to 88 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Lower Extremity Amputation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood pressure		every ten minutes from preinduction to 30minutes after sugery	Yes
Primary	Mean blood pressure		from arrival at recovery room until 20miutes after surgery at recovery room	Yes
Primary	Heart rate		every ten minutes from preinduction to 30minutes after sugery	Yes
Primary	Heart rate		from arrival at recovery room until 20miutes after surgery at recovery room	Yes