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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins; Regional Anaesthesia; Radiofrequency Ablation; Suprainguinal Fascia Iliaca Block
• Intervention / Treatment: Procedure: Spinal anesthesia (heavy bupivacaine); Procedure: SUPRAINGUINAL FACIA ILIACA BLOCK

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Zonguldak, Turkey (Türkiye)
    • Zonguldak Bulent Ecevit University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing varicose vein surgery at Zonguldak Bülent Ecevit University Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GROUP SPINAL	Procedure: Spinal anesthesia (heavy bupivacaine); 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.
Group SIFIB	Procedure: SUPRAINGUINAL 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-40 (QoR-40)	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.	FIRST DAY AFTER SURGERY

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleth Index		The Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.
Pain Scores	Assessed using the Numerical Rating Scale (NRS)	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

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: suprainguinal fascia iliaca block; QoR-40; pleth indeks (PI)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Anesthesia, Spinal
• Other Study ID Numbers: 2024/15-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No