Discharge TimeNCT07297082
Regional Anesthesia in Ambulatory Endovenous Ablation Surgery
A study testing Femoral nerve block and Spinal anesthesia in people with Discharge Time and Spinal Anesthesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Varicose veins represent irreversible, abnormal dilatations of the venous structures. They manifest as tortuous, swollen vessels visible beneath the skin of the lower extremities, particularly the feet and legs. Symptoms typically worsen with prolonged standing or sitting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Discharge Time, Spinal Anesthesia, Ambulatory Surgery
- What is being tested?
- Femoral nerve block and Spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 8 Apr 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II
- Body Mass Index (BMI) between 18-30 kg/m2
Who cannot join
- Patients under 18 and over 80 years of age
- ASA score III and above
- BMI below 18 or above 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia in Ambulatory Endovenous Ablation Surgery: Comparison of Postoperative Effects of Femoral Block and Low-Dose Spinal Anesthesia
Varicose veins represent irreversible, abnormal dilatations of the venous structures. They manifest as tortuous, swollen vessels visible beneath the skin of the lower extremities, particularly the feet and legs. Symptoms typically worsen with prolonged standing or sitting. In the early stages, conservative management options-such as the use of compression (elastic) stockings and frequent elevation of the legs-may be effective. In more advanced cases involving extensive varicosities, invasive interventions including sclerotherapy or endovascular ablation may be indicated. These procedures can be performed under local, regional, or general anesthesia.
Spinal anesthesia is a neuraxial technique that produces temporary sensory, motor, and sympathetic blockade through the subarachnoid administration of local anesthetics, with or without adjuvant agents. Clinically, it is commonly employed for surgeries involving the lower extremities, lower abdomen, perineal, gluteal, inguinal, and rectal regions, as well as select urologic and obstetric procedures.
A femoral nerve block is a regional anesthesia technique that involves ultrasound-guided injection of local anesthetic around the femoral nerve in the inguinal region. It provides effective analgesia for the anterior thigh, knee joint, and medial aspect of the lower leg. In endovenous laser ablation (EVLA), a femoral block can offer adequate sensory blockade to serve as a sole anesthetic technique.
- Being tested
- Femoral nerve block, Spinal anesthesia
- Keywords
- Ambulatory surgery, Endovenous laser ablation, Discharge Time, Femoral nerve block, Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
After monitoring, the patient is in the supine position and the femoral area on the side to be treated is sterilized. A femoral nerve block is then performed using 20 cc of 1% lidocaine using an ultrasound-guided blocking needle.
Spinal anesthesiaProcedure or surgery
After monitoring, patients will be placed in the lateral decubitus position. Following appropriate field sterilization, patients will receive unilateral spinal anesthesia with 6 mg bupivacaine. Five minutes after spinal anesthesia, patients will be placed in the supine position.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Active comparator | Not described Receives: Procedure: Femoral nerve block |
| Spinal anesthesia | Active comparator | Not described Receives: Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge time
The time (minutes) from the application of spinal anesthesia or femoral nerve block to the patients' discharge will be recorded as the discharge period
Measured: On the operation day
Secondary outcomes (2)
Motor block disappearing time
Time (minutes) to disappearance of complete motor block in the lower extremity
Measured: On the operation day
Sensorial block disappearing time
Time (minutes) to disappearance of sensorial block in the lower extremity
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start25 Dec 2025
- Primary completion2 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discharge TimeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İbrahim Topcu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297082
- Sponsor's protocol ID
- AEŞH-EK-2025-266
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia in Ambulatory Endovenous Ablation Surgery: Comparison of Postoperative Effects of Femoral Block and Low-Dose Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07297082
- Acronym / sponsor ID
- AEŞH-EK-2025-266
- Keywords
- Ambulatory surgery, Endovenous laser ablation, Discharge Time, Femoral nerve block, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 22 Dec 2025 (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.
Varicose veins represent irreversible, abnormal dilatations of the venous structures. They manifest as tortuous, swollen vessels visible beneath the skin of the lower extremities, particularly the feet and legs. Symptoms typically worsen with prolonged standing or sitting. In the early stages, conservative management options-such as the use of compression (elastic) stockings and frequent elevation of the legs-may be effective. In more advanced cases involving extensive varicosities, invasive interventions including sclerotherapy or endovascular ablation may be indicated. These procedures can be performed under local, regional, or general anesthesia.
Spinal anesthesia is a neuraxial technique that produces temporary sensory, motor, and sympathetic blockade through the subarachnoid administration of local anesthetics, with or without adjuvant agents. Clinically, it is commonly employed for surgeries involving the lower extremities, lower abdomen, perineal, gluteal, inguinal, and rectal regions, as well as select urologic and obstetric procedures.
A femoral nerve block is a regional anesthesia technique that involves ultrasound-guided injection of local anesthetic around the femoral nerve in the inguinal region. It provides effective analgesia for the anterior thigh, knee joint, and medial aspect of the lower leg. In endovenous laser ablation (EVLA), a femoral block can offer adequate sensory blockade to serve as a sole anesthetic technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Active comparator | Procedure: Femoral nerve block |
| Spinal anesthesia | Active comparator | Procedure: Spinal anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-80 years
- American Society of Anesthesiologists (ASA) score I-II
- Body Mass Index (BMI) between 18-30 kg/m2
Key exclusion criteria (3 listed)
- Patients under 18 and over 80 years of age
- ASA score III and above
- BMI below 18 or above 30 kg/m2
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 |
|---|---|---|
| Femoral nerve blockAfter monitoring, the patient is in the supine position and the femoral area on the side to be treated is sterilized. A femoral nerve block is then performed using 20 cc of 1% lidocaine using an ultrasound-guided blocking needle. | Procedure or surgery | Femoral Nerve Block |
| Spinal anesthesiaAfter monitoring, patients will be placed in the lateral decubitus position. Following appropriate field sterilization, patients will receive unilateral spinal anesthesia with 6 mg bupivacaine. Five minutes after spinal anesthesia, patients will be placed in the supine position. | Procedure or surgery | Spinal anesthesia |
Primary outcome
Discharge time
Time frame: On the operation day
The time (minutes) from the application of spinal anesthesia or femoral nerve block to the patients' discharge will be recorded as the discharge period
2 secondary outcomes
Motor block disappearing time
Time frame: On the operation day
Sensorial block disappearing time
Time frame: On the operation day
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 13 Apr 2026.
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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?
A study testing Femoral nerve block and Spinal anesthesia in people with Discharge Time and Spinal Anesthesia, run by Ankara Etlik City Hospital 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 3 inclusion and 3 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 13 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?
Discharge time (time frame: On the operation day). 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 13 Apr 2026.