Regional Anesthesia and Recovery After Varicose Vein RFA

NCT07514000 | Completed

• 1 other identifier: 2024/15-4
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pleth Index

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

• Pain Scores

  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

Study Arms (2)

GROUP SPINAL

Procedure: Spinal anesthesia (heavy bupivacaine)

Group SIFIB

Procedure: SUPRAINGUINAL FACIA ILIACA BLOCK

Interventions

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.

GROUP SPINAL

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.

Group SIFIB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing varicose vein surgery at Zonguldak Bülent Ecevit University Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University Hospital

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Varicose Veins

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 7, 2026
• Study Start: July 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)