Suprainguinal Fascia Iliaca BlockNCT07514000
Regional Anesthesia and Recovery After Varicose Vein RFA
An observational study of Suprainguinal Fascia Iliaca Block and Varicose Veins, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suprainguinal Fascia Iliaca Block, Varicose Veins, Radiofrequency Ablation
- What is being tested?
- Spinal anesthesia (heavy bupivacaine) and SUPRAINGUINAL FACIA ILIACA BLOCK
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing varicose vein surgery at Zonguldak Bülent Ecevit University Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University Hospital
Zonguldak
About this study
Official title: 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.
- Conditions
- Suprainguinal Fascia Iliaca Block, Varicose Veins, Radiofrequency Ablation, Regional Anaesthesia
- Being tested
- Spinal anesthesia (heavy bupivacaine), SUPRAINGUINAL FACIA ILIACA BLOCK
- Keywords
- QoR-40, suprainguinal fascia iliaca block, pleth indeks (PI)
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia (heavy bupivacaine)Procedure or surgery
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.
SUPRAINGUINAL FACIA ILIACA BLOCKProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP SPINAL | Not described Receives: Procedure: Spinal anesthesia (heavy bupivacaine) | |
| Group SIFIB | Not described Receives: Procedure: SUPRAINGUINAL FACIA ILIACA BLOCK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: FIRST DAY AFTER SURGERY
Secondary outcomes (2)
Pleth Index
Measured: The Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.
Pain Scores
Assessed using the Numerical Rating Scale (NRS)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jul 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suprainguinal Fascia Iliaca BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Dere, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514000
- Sponsor's protocol ID
- 2024/15-4
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Regional Anesthesia Methods on the Quality of Recovery in Radiofrequency Ablation of Varicose Veins
- ClinicalTrials.gov ID
- NCT07514000
- Acronym / sponsor ID
- 2024/15-4
- Conditions
- Suprainguinal Fascia Iliaca Block, Varicose Veins, Radiofrequency Ablation, Regional Anaesthesia
- Keywords
- QoR-40, suprainguinal fascia iliaca block, pleth indeks (PI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP SPINAL | – | Procedure: Spinal anesthesia (heavy bupivacaine) |
| Group SIFIB | – | Procedure: SUPRAINGUINAL FACIA ILIACA BLOCK |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing varicose vein surgery at Zonguldak Bülent Ecevit University Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | GROUP SPINAL |
| SUPRAINGUINAL 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. | Procedure or surgery | Group SIFIB |
Primary outcome
Quality of Recovery-40 (QoR-40)
Time frame: FIRST DAY AFTER SURGERY
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.
2 secondary outcomes
Pleth Index
Time frame: The Pleth Index was measured preoperatively and every 10 minutes during the intraoperative period.
Pain Scores
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suprainguinal Fascia Iliaca Block and Varicose Veins, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-40 (QoR-40) (time frame: FIRST DAY AFTER SURGERY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.