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Regional Anesthesia and Recovery After Varicose Vein RFA

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07514000
Enrollment
40
Registered
2026-04-07
Start date
2024-07-01
Completion date
2025-07-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiofrequency Ablation, Regional Anaesthesia, Suprainguinal Fascia Iliaca Block, Varicose Veins

Keywords

QoR-40, suprainguinal fascia iliaca block, pleth indeks (PI)

Brief 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.

Interventions

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.

PROCEDURESUPRAINGUINAL FACIA ILIACA BLOCK

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.

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery-40 (QoR-40)FIRST DAY AFTER SURGERYPatients 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

MeasureTime frameDescription
Pleth IndexThe Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.
Pain ScoresMeasurements 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 painAssessed using the Numerical Rating Scale (NRS)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026