Regional Anesthesia for Percutaneous Transluminal Angioplasty

NCT ID: NCT05737225

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-24

Study Completion Date

2023-05-01

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.

Detailed Description

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Conditions

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Peripheral Artery Occlusive Disease Percutaneous Transluminal Angioplasty

Keywords

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percutaneous transluminal angioplasty tissue oxygenation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Popliteal sciatic nerve block group

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

Near Infrared Spectroscopy (NIRS)

Intervention Type 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

patients who will undergo percutaneous transluminal angioplasty (PTA) procedure

Near Infrared Spectroscopy (NIRS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Demet Coşkun

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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775 (24.10.2022)

Identifier Type: -

Identifier Source: org_study_id