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

NCT06693245 · tracked via the Priya Life Science China tracker

Sponsor

Chengdu University of Traditional Chinese Medicine

Phase

Observational

Started

2024-12-01

Last updated

2024-11-18

Condition(s) studied

Vascular Disease，PeripheralVenous Insufficiency of LegVaricose Veins of Lower Limb

Investigational drug(s) / intervention(s)

VAS scores of the puncture

VAS scores of the puncture: 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

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;

Primary outcome measure(s)

Visual Analogue Scale (VAS) Pain Score — during operation
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.
Basic data related to surgery — intraoperative
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.

Trial sites (1)

Facility	City	Region	Status
Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06693245 on ClinicalTrials.gov ↗ ← All trials in China