NCT07297082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

December 9, 2025

Last Update Submit

April 8, 2026

Conditions

Discharge TimeSpinal AnesthesiaAmbulatory SurgeryFemoral Nerve Block

Keywords

Ambulatory surgeryEndovenous laser ablationDischarge TimeFemoral nerve blockSpinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

    On the operation day

Secondary Outcomes (2)

  • Motor block disappearing time

    On the operation day

  • Sensorial block disappearing time

    On the operation day

Study Arms (2)

Femoral Nerve Block

ACTIVE COMPARATOR
Procedure: Femoral nerve block

Spinal anesthesia

ACTIVE COMPARATOR
Procedure: Spinal anesthesia

Interventions

Femoral nerve blockPROCEDURE

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.

Femoral Nerve Block
Spinal anesthesiaPROCEDURE

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.

Spinal anesthesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İbrahim Topcu

Etimesgut, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

December 25, 2025

Primary Completion

April 2, 2026

Study Completion

April 8, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

TU(1)