Regional Anesthesia for Percutaneous Transluminal Angioplasty

• Sponsor: Gazi University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05737225
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 7.2
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Occlusive Disease; Percutaneous Transluminal Angioplasty	Device: Near Infrared Spectroscopy (NIRS)

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 70 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Effect of Regional Anesthesia Method on Tissue Oxygenation in Patients Who Will Undergo Percutaneous Transluminal Angioplasty
• Actual Study Start Date: Sep 24, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Popliteal sciatic nerve block group regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure	Device: 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.
Control group patients who will undergo percutaneous transluminal angioplasty (PTA) procedure	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gazi University	Ankara		Turkey	06490

Sponsors and Collaborators

• Gazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Demet Coşkun, Prof. Dr., Gazi University
• ClinicalTrials.gov Identifier: NCT05737225
• Other Study ID Numbers: 775 (24.10.2022)
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 21, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Demet Coşkun, Prof. Dr., Gazi University: percutaneous transluminal angioplasty; tissue oxygenation
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Feb 21, 2023