Regional Anesthesia for Percutaneous Transluminal Angioplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Peripheral Artery Occlusive Disease, Percutaneous Transluminal Angioplasty

Intervention / Treatment
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* Device: Near Infrared Spectroscopy (NIRS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Popliteal sciatic nerve block group<br>regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure | Device: Near Infrared Spectroscopy (NIRS)<br>* 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.<br>|
| Control group<br>patients who will undergo percutaneous transluminal angioplasty (PTA) procedure | Device: Near Infrared Spectroscopy (NIRS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Oxygenation | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous transluminal angioplasty, tissue oxygenation