CompletedNot Applicable

Regional Anesthesia and Recovery After Varicose Vein RFA

Turkey (Türkiye)40 participantsStarted 2024-07-01

Plain-language summary

This prospective observational study aims to compare the effects of spinal anesthesia and supra-inguinal fascia iliac block (SIFIB) on the quality of postoperative recovery in endovenous radiofrequency ablation (RFA) of varicose veins. The primary outcome measure of the study is the QoR-40 quality of recovery score. Secondary outcome measures include postoperative pain scores (VAS/NRS), motor block level (Bromage Scale), perfusion index (PI), time to first mobilization, and patient and surgeon satisfaction.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age Profile: Adults aged between 18 and 65 years. * Physical Status: Patients classified as American Society of Anesthesiologists (ASA) Physical Status I, II, or III. * Informed Consent: Patients who voluntarily agreed to participate and provided written informed consent. * Cognitive Status: Patients who were conscious, oriented, and capable of cooperating with the pain assessment scales (NRS) and the QoR-40 questionnaire. Exclusion Criteria: * Venous Pathology: Presence of deep venous insufficiency (e.g., iliac or femoral vein obstruction, iliac vein stenosis) or acute deep vein thrombosis (DVT) in the lower extremity. * Systemic Diseases: Combined cardiac, pulmonary, hepatic, or renal dysfunction. * Hematological Disorders: Coagulation disorders or active bleeding diathesis. * Neurological/Cognitive Status: Presence of dementia, cognitive impairment, or inability to cooperate during the procedure. * Local Contraindications: Active infection at the site of the regional anesthesia intervention or surgical field. * Patient Refusal: Patients who declined regional anesthesia or had a known allergy to local anesthetics.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Recovery-40 (QoR-40)

Timeframe: FIRST DAY AFTER SURGERY

Trial details

NCT IDNCT07514000

SponsorZonguldak Bulent Ecevit University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Suprainguinal Fascia Iliaca Block trials