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Active Not Recruiting NCT07907315

Pain During Heat Treatment for Lower Extremity Varicose Veins: Radiofrequency vs. Microwave

Conditions: Lower Extremity Varicose Veins, Radiofrequency Ablation, Microwave Ablation, Pain Measurement

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Enrollment: 130
Sponsor: Chunshui He

Location: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Chengdu Sichuan

Summary

This study compares two common heat-based procedures for treating varicose veins in the legs: radiofrequency ablation (RFA) and microwave ablation (MWA). Both treatments use heat to close off diseased veins, but they work differently-RFA heats through direct contact, while MWA uses microwave energy that spreads heat more widely. The main question is: Which procedure causes less pain during the surgery? Participants will be randomly assigned to receive either RFA or MWA. Since the surgery is done under local anesthesia (not general anesthesia), patients remain awake throughout. We will measure their pain at four key moments: When the needle is first inserted Right after injecting the numbing fluid (tumescent anesthesia) During the heat treatment itself At the end of the entire procedure We will also track how much numbing fluid is used, how long the procedure takes, and any side effects. Patients will be followed for 30 days after surgery to monitor recovery and satisfaction. The goal is to find out whether one method is more comfortable for patients, and to identify which factors (such as age, vein size, or anxiety level) affect pain during each procedure. This will help doctors choose the best approach for each patient and improve the overall treatment experience.

Eligibility Criteria

Inclusion Criteria: 1. Age 18 to 75 years, male or female. 2. Confirmed diagnosis of great saphenous vein (GSV) trunk reflux with a reflux time \>0.5 seconds on lower extremity duplex ultrasound. 3. CEAP clinical classification of C2 to C6 (inclusive). 4. GSV trunk diameter (thigh segment) measuring 4 to 12 mm on pre-operative ultrasound. 5. Planned to undergo endovenous thermal ablation treatment for varicose veins. 6. Willing and able to provide written informed consent to participate in the study. Exclusion Criteria: 1. History of deep vein thrombosis (DVT) in the ipsilateral lower extremity. 2. ior surgical stripping or endovenous ablation treatment on the ipsilateral GSV. 3. Acute superficial venous thrombophlebitis in the ipsilateral lower extremity at the time of screening. 4. Concurrent lower extremity arterial disease with an ankle-brachial index (ABI) \3 times the upper limit of normal). 8. Severe renal impairment (estimated glomerular filtration rate \1.5 or platelet count \3 months). 14. Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.

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Source: ClinicalTrials.gov (NCT07907315). StuddyBuddy aggregates publicly available trial information.