Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
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.