Observation of Pain During Radiofrequency Ablation of Saphenous Vein，and Analysis of Related Factors

NCT07683871 | Completed

• 1 other identifier: chengduUTCMvs6
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study is a single-center prospective observational study, which recorded the pain scores of patients at four time nodes during surgery (puncture and catheterization, injection of swelling fluid, radiofrequency generator work, and end of surgery), and analyzed the correlation between intraoperative pain and age, gender, BMI and other factors, so as to summarize and improve the details of surgery and reduce patients' intraoperative pain.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Puncture catheterization

  The pain during puncture and catheterization mainly comes from needle breakage, local anesthetic infiltration and vascular sheath insertion, the 7F vascular puncture sheath group was used in this study, the diameter of the puncture needle is 1.27mm, the pain during skin puncture is stronger than that of the syringe needle used for intravenous or intramuscular injection, there is a well-designed randomized controlled use of an automatic injection device to standardize the injection parameters, and the use of smaller needles also forces the injector to slow down the injection rate, which can reduce the pain of the patient

  At the time of surgery

• Inject swollen fluid

  In this study, a 0.7mm needle was used to inject lidocaine into the skin around the puncture point, which can be replaced with a 0.5mm needle to slow down the injection rate of lidocaine, reduce the stinging sensation of the patient, and place the vascular sheath after the local anesthetic infiltrates the skin, which can slightly reduce the pain of the vascular sheath entering the blood vessel through the skin. Similarly, a 0.7mm needle is used to inject swelling fluid from the puncture point along the main trunk of the saphenous vein, the longer the length of the patient's ablation vein, the number of skin breaks will increase, but the patient's pain will not increase with the accumulation of skin breaks, and the operator can reduce the pain of the patient's injection of swelling fluid by squeezing, pressing, stretching the skin, and inserting the needle vertically

  At the time of surgery

Study Arms (1)

Observation of Pain During Radiofrequency Ablation of Saphenous Vein，and Analysis of Related Factors

Among the 155 patients were evaluated by our team with CEAP grading and ultrasound measurements to record the diameter of the saphenous vein before surgery, and the procedure of radiofrequency ablation of the saphenous vein trunk supplemented with sclerotherapy was applied to record the data of the operating room temperature, puncture site, and the VAS scores of the puncture and tube placement, injection of the swelling fluid, radiofrequency generator, and the end of the procedure. The patients' intraoperative pain scores were descriptively analyzed to assess the degree of intraoperative pain, and non，parametric tests were applied to analyze the correlation between preoperative and intraoperative factors and intraoperative pain.

Procedure: VAS scores of the puncture

Interventions

VAS scores of the puncture PROCEDURE

Observation of Pain During Radiofrequency Ablation of Saphenous Vein，and Analysis of Related Factors

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 April 2023 to September 2023 who were admitted to the hospital and underwent RFA 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;
• radiofrequency 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

Location

Related Publications (7)

• Kubat E, Unal CS, Geldi O, Cetin E, Keskin A. What is the optimal treatment technique for great saphenous vein diameter of >/=10 mm? Comparison of five different approaches. Acta Chir Belg. 2021 Apr;121(2):94-101. doi: 10.1080/00015458.2019.1684008. Epub 2019 Oct 25.

  PMID: 31635532 RESULT

• Bozoglan O, Mese B, Eroglu E, Erdogan MB, Erdem K, Ekerbicer HC, Yasim A. Comparison of Endovenous Laser and Radiofrequency Ablation in Treating Varicose Veins in the Same Patient. Vasc Endovascular Surg. 2016 Jan;50(1):47-51. doi: 10.1177/1538574415625813. Epub 2016 Jan 14.

  PMID: 26767802 RESULT

• 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 RESULT

• 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 RESULT

• Arendt-Nielsen L, Egekvist H, Bjerring P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res. 2006 Mar-Jun;23(1-2):37-43. doi: 10.1080/08990220600700925.

  PMID: 16846958 RESULT

• Egekvist H, Bjerring P, Arendt-Nielsen L. Pain and mechanical injury of human skin following needle insertions. Eur J Pain. 1999 Mar;3(1):41-49. doi: 10.1053/eujp.1998.0099.

  PMID: 10700336 RESULT

• Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol. 2007 Sep;1(5):725-9. doi: 10.1177/193229680700100517.

  PMID: 19885141 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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: July 29, 2024
• First Posted: July 6, 2026
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 6, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)