Observing pain during microwave treatment for varicose veins

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

This study looks at how much pain patients feel during microwave treatment for varicose veins to see if different factors like age and weight affect their experience, with the goal of making the procedure more comfortable.

Quick facts

• Study type: Observational
• Enrollment: 155 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Chengdu University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06693245 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess pain levels experienced by patients undergoing microwave ablation for great saphenous vein varicosities at various stages of the procedure. It records pain scores at four key time points during surgery and analyzes how factors such as age, gender, and body mass index correlate with intraoperative pain. The goal is to identify ways to improve surgical techniques and reduce pain for patients undergoing this treatment. By focusing on the patient's experience, the study seeks to enhance the overall quality of care in vascular surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with primary varicose veins requiring treatment of the great saphenous vein.

Not a fit: Patients with a history of deep vein thrombosis or those who have had previous varicose vein surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies during microwave ablation, enhancing patient comfort and satisfaction.

How similar studies have performed: While there is limited research specifically on intraoperative pain during microwave ablation, studies on pain management in similar vascular procedures have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Age≥ 18 years old, ≤ 90 years old;
2. the patient's life expectancy is greater than 12 months;
3. 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;
4. Doppler ultrasound confirmed that the diameter of GSV was greater than 3mm and less than 12mm when standing;
5. Doppler ultrasound confirms that GSV is located in the saphenofascia or the distance between GSV and the skin surface is \>1cm;
6. endovenous microwave ablation treatment only for unilateral GSV walking area;
7. The patient is willing to cooperate with the completion of the examination specified in the protocol.

Exclusion Criteria:

1. GSV thrombosis, or combined with deep vein thrombosis, or previous history of deep vein thrombosis and pulmonary embolism;
2. patients with recurrence after prior VVs-related surgery (C2r);
3. the GSV trunk is severely distorted, and it is expected that the catheter will not be able to pass;
4. Severe ischemia of the lower limbs, Ankle brachial pressure index (ABPI) \< 0.8;
5. Known allergy to the drugs and device materials involved in the study;
6. Previously implanted with a pacemaker or defibrillator, and currently receiving regular anticoagulation therapy (such as warfarin, heparin);
7. Pregnant or lactating females;
8. Patients who are unable or unwilling to participate in the study;
9. Participating in the research of other drugs or devices;
10. Skin malignancies other than non-melanoma that are being treated;
11. daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain caused by venous disease;
12. The investigator judged that endovenous treatment was not suitable;

Where this trial is running

Chengdu, Sichuan

• Hospital of Chengdu University of Traditional Chinese Medicine — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Chunshui He, Doctor

Conditions Vascular Disease，Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb; Varicose veins of the lower extremities; Endovenous Microwave Ablation; intraoperative pain; visual analogue scale of pain