Regional Anesthesia for Percutaneous Transluminal Angioplasty

December 19, 2023 updated by: Demet Coşkun, Gazi University

The Effect of Regional Anesthesia Method on Tissue Oxygenation in Patients Who Will Undergo Percutaneous Transluminal Angioplasty

In this study, the effects of regional anesthesia method applied in patients who will undergo percutaneous transluminal angioplasty for lower extremity revascularization will be investigated comparatively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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

  • Turkey
      • Ankara, Turkey, 06490
        • Gazi University

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

ASA I-III patients over the age of 18 who have been decided to perform elective PTA as a treatment method for peripheral arterial disease will be included in the study.

Description

Inclusion Criteria:

  • Age: > 18 years
  • Peripheral artery occlusive disease
  • Eligibility for PTA

Exclusion Criteria:

  • Patients' refusal
  • Under the age of 18
  • Language problems (not knowing turkish)
  • Psychological or mental disorders.
  • Disturbance of Conscious level.
  • Uncooperative patients
  • Those who are allergic to anesthetic drugs to be used
  • Those with contraindications for the application of peripheral nerve block (coagulopathy, skin infection at the block site)
  • need for endotracheal intubation or general anesthesia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Popliteal sciatic nerve block group
regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure
Device: Near Infrared Spectroscopy (NIRS)
We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure.
Control group
patients who will undergo percutaneous transluminal angioplasty (PTA) procedure
Device: Near Infrared Spectroscopy (NIRS)
We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Oxygenation
Time Frame: During procedure
Tissue oxygenation will be measured from both lower extremities by Near Infrared Spectroscopy for 30 min after popliteal sciatic nerve block and during procedure.
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Temperature of Lower Extremities
Time Frame: During procedure
Body temperature will be measured simultaneously at 0-5-10-15-20-25 and 30th minutes after the application of the popliteal sciatic nerve block
During procedure
Patient Satisfaction Score
Time Frame: 15 minutes after procedure
Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.
15 minutes after procedure
Surgeon Satisfaction Score
Time Frame: 15 minutes after procedure
Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.
15 minutes after procedure

Collaborators and Investigators

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

Sponsor

Gazi 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 (Actual)

September 24, 2022

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 775 (24.10.2022)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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