Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors
Recruiting now
Conditions studied: Vascular Disease，Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb
In brief
Objective: This study is a single-center prospective observational research that recorded patients' pain scores at four time points during surgery (puncture and catheter insertion, swelling fluid injection, microwave generator operation, and end of surgery). It analyzed the correlation between pain during microwave ablation treatment for great saphenous vein varicosities and factors such as age, gender, body mass index, volume of swelling fluid used, and others, in order to summarize and improve surgical details to reduce patients' intraoperative pain.
Key facts
- Study ID
- NCT06693245
- Run by
- Chengdu University of Traditional Chinese Medicine
- People needed
- 155
- Starts
- 2024-12-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-18
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age≥ 18 years old, ≤ 90 years old;
- the patient's life expectancy is greater than 12 months;
- The clinical diagnosis is primary VVs, CEAP classification C2-C6, and the GSV segment needs to be treated, including pain, burning sensation, heaviness, fatigue, itchy skin, night cramps and other clinical symptoms;
- Doppler ultrasound confirmed that the diameter of GSV was greater than 3mm and less than 12mm when standing;
- Doppler ultrasound confirms that GSV is located in the saphenofascia or the distance between GSV and the skin surface is >1cm;
- endovenous microwave ablation treatment only for unilateral GSV walking area;
- The patient is willing to cooperate with the completion of the examination specified in the protocol.
You may not qualify if…
- GSV thrombosis, or combined with deep vein thrombosis, or previous history of deep vein thrombosis and pulmonary embolism;
- patients with recurrence after prior VVs-related surgery (C2r);
- the GSV trunk is severely distorted, and it is expected that the catheter will not be able to pass;
- Severe ischemia of the lower limbs, Ankle brachial pressure index (ABPI) < 0.8;
- Known allergy to the drugs and device materials involved in the study;
- Previously implanted with a pacemaker or defibrillator, and currently receiving regular anticoagulation therapy (such as warfarin, heparin);
- Pregnant or lactating females;
- Patients who are unable or unwilling to participate in the study;
- Participating in the research of other drugs or devices;
- Skin malignancies other than non-melanoma that are being treated;
- daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain caused by venous disease;
- The investigator judged that endovenous treatment was not suitable;
Where it is running
- Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, China (enrolling)
Full record on ClinicalTrials.gov
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