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Regional Anesthesia in Ambulatory Endovenous Ablation Surgery

NCT ID: NCT07297082

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Discharge Time Spinal Anesthesia Ambulatory Surgery Femoral Nerve Block

Keywords

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Ambulatory surgery Endovenous laser ablation Discharge Time Femoral nerve block Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Femoral Nerve Block

Group Type ACTIVE_COMPARATOR

Femoral nerve block

Intervention Type PROCEDURE

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 anesthesia

Group Type ACTIVE_COMPARATOR

Spinal anesthesia

Intervention Type PROCEDURE

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.

Interventions

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Femoral nerve block

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.

Intervention Type PROCEDURE

Spinal anesthesia

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria

* Patients under 18 and over 80 years of age
* ASA score III and above
* BMI below 18 or above 30 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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İbrahim Topcu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İbrahim Topcu

Etimesgut, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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İbrahim Topcu, MD

Role: CONTACT

Phone: 00905437860316

Email: [email protected]

Musa Zengin, Associate Professor

Role: CONTACT

Phone: 00905307716235

Email: [email protected]

Facility Contacts

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İbrahim MD Topcu, MD

Role: primary

Musa Assoc.Prof Zengin, Associate Professor

Role: backup

Other Identifiers

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AEŞH-EK-2025-266

Identifier Type: -

Identifier Source: org_study_id