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

NCT06693245 | Recruiting

• 1 other identifier: ChengduUTCMvs7
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Disease，Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb

Keywords

Varicose veins of the lower extremities; Endovenous Microwave Ablation; intraoperative pain; visual analogue scale of pain

Outcome Measures

Primary Outcomes (2)

• 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.

  during operation

• 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.

  intraoperative

Study Arms (1)

Observation of Pain and Analysis of Related Factors During Microwave Ablation Treatment of Saphenous

Among 155 patients, our team measured the diameter of the great saphenous vein preoperatively according to the CEAP classification and ultrasound measurements. 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.

Procedure: VAS scores of the puncture

Interventions

VAS scores of the puncture PROCEDURE

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.

Observation of Pain and Analysis of Related Factors During Microwave Ablation Treatment of Saphenous

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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

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;

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (7)

• Yang X, Li J, Bai X, Zhou L, Xu W. Endovenous Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Lower Limb Varicose Veins. Ann Vasc Surg. 2024 Jan;98:301-308. doi: 10.1016/j.avsg.2023.06.024. Epub 2023 Jul 7.

  PMID: 37423329 BACKGROUND

• Nandhra S, Wallace T, El-Sheikha J, Leung C, Carradice D, Chetter I. A Randomised Clinical Trial of Buffered Tumescent Local Anaesthesia During Endothermal Ablation for Superficial Venous Incompetence. Eur J Vasc Endovasc Surg. 2018 Nov;56(5):699-708. doi: 10.1016/j.ejvs.2018.05.017. Epub 2018 Jun 29.

  PMID: 30392525 BACKGROUND

• Usach I, Martinez R, Festini T, Peris JE. Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv Ther. 2019 Nov;36(11):2986-2996. doi: 10.1007/s12325-019-01101-6. Epub 2019 Oct 5.

  PMID: 31587143 BACKGROUND

• Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.

  PMID: 21154371 BACKGROUND

• Anuforo A, Evbayekha E, Agwuegbo C, Okafor TL, Antia A, Adabale O, Ugoala OS, Okorare O, Phagoora J, Alagbo HO, Shamaki GR, Disreal Bob-Manuel T. Superficial Venous Disease-An Updated Review. Ann Vasc Surg. 2024 Aug;105:106-124. doi: 10.1016/j.avsg.2024.01.009. Epub 2024 Apr 5.

  PMID: 38583765 BACKGROUND

• Li Y, Wu W, Li Y, Li J, Sun M. Efficacy and safety of endovenous microwave ablation versus laser ablation for great saphenous vein varicosis: study protocol for a multicentre, randomised controlled non-inferiority trial. BMJ Open. 2022 May 25;12(5):e059213. doi: 10.1136/bmjopen-2021-059213.

  PMID: 35613801 BACKGROUND

• Hu J, Zhao T, Geng W, Lu Y, Zhao XF, Li YZ, Tang YQ, Liu JW, Wang LY, Janiak C, Yang XY, Su BL. Correction: Synthesis of hydrophobic and hydrophilic TiO2 nanofluids for transformable surface wettability and photoactive coating. Chem Commun (Camb). 2019 Sep 24;55(77):11642. doi: 10.1039/c9cc90390a.

  PMID: 31512684 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chunshui He, Doctor

CONTACT

86-18981885601; Chunshuihe@msn.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)