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CompletedNCT07514000

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
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Zonguldak Bulent Ecevit University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURESpinal 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.
PROCEDURESUPRAINGUINAL FACIA ILIACA BLOCKAfter 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.

Timeline

Start date
2024-07-01
Primary completion
2025-07-30
Completion
2025-07-30
First posted
2026-04-07
Last updated
2026-04-07

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07514000. Inclusion in this directory is not an endorsement.