- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297082
Regional Anesthesia in Ambulatory Endovenous Ablation Surgery
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Etimesgut, Ankara, Turkey (Türkiye), 06170
- İbrahim Topcu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
On the operation day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor block disappearing time
Time Frame: On the operation day
|
Time (minutes) to disappearance of complete motor block in the lower extremity
|
On the operation day
|
|
Sensorial block disappearing time
Time Frame: On the operation day
|
Time (minutes) to disappearance of sensorial block in the lower extremity
|
On the operation day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEŞH-EK-2025-266
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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