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NCT Number: NCT07514000

Regional Anesthesia and Recovery After Varicose Vein RFA

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.

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Key information

Conditions

Suprainguinal Fascia Iliaca Block Cardiovascular Diseases Radiofrequency Ablation Regional Anaesthesia Varicose Veins Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bulent Ecevit University Hospital

Zonguldak, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Spinal anesthesia (heavy bupivacaine)

Procedure

Following standard monitoring (ECG, non-invasive blood pressure, SpO2, perfusion index), the patient will be prepared in a sitting position. Under aseptic conditions, the L3-L4 or L4-L5 intervertebral space will be identified using a midline approach; a 25-gauge Quincke spinal needle will be inserted into the subarachnoid space. After confirmation of free CSF flow, hyperbaric bupivacaine 0.5% will be administered intrathecally.

SUPRAINGUINAL FACIA ILIACA BLOCK

Procedure

After standard monitoring (ECG, non-invasive blood pressure, SpO2, perfusion index), the patient will be placed in the supine position. Under aseptic conditions, a high-frequency linear ultrasound probe will be placed under the inguinal ligament to visualize the iliac fascia compartment; then, the probe will be slid cephalad over the inguinal ligament to identify the supra-inguinal approach point. Using the in-plane technique, a 22-gauge, 50 mm block needle will be passed through the iliac fascia under real-time ultrasound guidance. Negative aspiration will be confirmed by ultrasonographic visualization of the characteristic hydrodissection between the iliac fascia and the iliopsoas muscle. 40 mL of 0.20% bupivacaine local anesthetic will be injected.

Primary outcomes

  1. Quality of Recovery-40 (QoR-40)

    Time frame: FIRST DAY AFTER SURGERY

    Patients were asked to complete the Quality of Recovery-40 (QoR-40) questionnaire preoperatively and at 24 hours postoperatively. The QoR-40 score ranges from 40 to 200, with higher scores indicating better quality of recovery.

Secondary outcomes

  1. Pleth Index

    Time frame: The Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.

  2. Pain Scores

    Time frame: Measurements were taken at postoperative hours 0,2,4,6,12 and 24. The NRS score ranges from 0 to 10, with higher scores indicating more severe pain

    Assessed using the Numerical Rating Scale (NRS)

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

The Effects of Regional Anesthesia Methods on the Quality of Recovery in Radiofrequency Ablation of Varicose Veins

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 7, 2026
Registry last updated
Apr 27, 2026

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.

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