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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorChengdu University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

Patients diagnosed with primary VVs from December 2024 to December 2025 who were admitted to the hospital and underwent endovenous microwave ablation treatment for the main trunk of the saphenous vein

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • VAS scores of the puncture

    Procedure/Surgery

    All patients were evaluated by our team with CEAP grading and ultrasound measurements to record the diameter of the saphenous vein before surgery。We performed endovenous microwave ablation of the great saphenous vein along with foam sclerotherapy and point stripping treatment. We documented the operating room temperature, puncture site, VAS scores during puncture and catheter placement, the amount of injected tumescent fluid, radiofrequency generator used, and data at the conclusion of the surgery. A descriptive analysis of intraoperative pain scores was conducted to evaluate the level of pain experienced during the surgery. A nonparametric test was utilized to analyze the relationship between preoperative and intraoperative factors and the level of pain experienced during the surgery.

Treatment groups

155 Participants
are divided into 1 treatment group
Group A: Observation of Pain and Analysis of Related Factors During Microwave Ablation Treatment of Saphenous1 intervention

Trial outcomes

Primary outcomes

1

Visual Analogue Scale (VAS) Pain Score

We mainly record the VAS pain scores during local anesthetic injection, needle puncture, catheter placement, swollen anesthetic injection, microwave generator operation, and at the end of the surgery.

Time frame
during operation
2

Basic data related to surgery

We also documented the patient's heart rate, blood pressure, oxygen saturation, along with the temperature of the operating room, location of puncture, number of incisions, and volume of injected swelling fluid, among others. These data are recorded to explore their correlation with the intraoperative VAS pain score.

Time frame
intraoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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