Regional Anesthesia in Ambulatory Endovenous Ablation Surgery

NCT ID: NCT07297082

Last Updated: 2025-12-29

Basic Information

• 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

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.

Conditions

Discharge Time; Spinal Anesthesia; Ambulatory Surgery; Femoral Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

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

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

İbrahim Topcu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İbrahim Topcu

Etimesgut, Ankara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

İbrahim Topcu, MD

Role: CONTACT

ibrahimtpc78@gmail.com

00905437860316

Musa Zengin, Associate Professor

Role: CONTACT

musazengin@gmail.com

00905307716235

Facility Contacts

İbrahim MD Topcu, MD

Role: primary

ibrahimtpc78@gmail.com

00905437860316

Musa Assoc.Prof Zengin, Associate Professor

Role: backup

musazengin@gmail.com

00905307716235

Other Identifiers

AEŞH-EK-2025-266

Identifier Type: -

Identifier Source: org_study_id