Regional Anesthesia for Percutaneous Transluminal Angioplasty

NCT05737225 | Completed

• 1 other identifier: 775 (24.10.2022)
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Occlusive Disease; Percutaneous Transluminal Angioplasty

Keywords

percutaneous transluminal angioplasty; tissue oxygenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Body Temperature of Lower Extremities

  During procedure

• Patient Satisfaction Score

  15 minutes after procedure

• Surgeon Satisfaction Score

  15 minutes after procedure

Study Arms (2)

Popliteal sciatic nerve block group

regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure

Device: Near Infrared Spectroscopy (NIRS)

Control group

patients who will undergo percutaneous transluminal angioplasty (PTA) procedure

Device: Near Infrared Spectroscopy (NIRS)

Interventions

Near Infrared Spectroscopy (NIRS) DEVICE

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; Popliteal sciatic nerve block group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 21, 2023
• Study Start: September 24, 2022
• Primary Completion: April 17, 2023
• Study Completion: May 1, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)