Regional Anesthesia for Percutaneous Transluminal Angioplasty

Completed

• Conditions: Percutaneous Transluminal Angioplasty; Peripheral Artery Occlusive Disease
• Interventions: Device: Near Infrared Spectroscopy (NIRS)

• Registration Number: NCT05737225
• Lead Sponsor: Gazi University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-24
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-19
• Study First Posted: 2023-02-21
• Primary Completion: 2023-04-17
• Study Completion: 2023-05-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Popliteal sciatic nerve block group	Near Infrared Spectroscopy (NIRS)	regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure
Control group	Near Infrared Spectroscopy (NIRS)	patients who will undergo percutaneous transluminal angioplasty (PTA) procedure

Primary Outcome Measures

Name	Time	Method
Tissue Oxygenation	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Score	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.
Surgeon Satisfaction Score	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.
Body Temperature of Lower Extremities	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

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey