Skip to main content
OpenTrials
Completed

NCT Number: NCT05737225

Regional Anesthesia for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral Artery Occlusive Disease Percutaneous Transluminal Angioplasty Peripheral Arterial Occlusive Disease 1

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, 06490, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.