- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07683871
Observation of Pain During Radiofrequency Ablation of Saphenous Vein,and Analysis of Related Factors
28. Juni 2026 aktualisiert von: Chunshui He, Chengdu University of Traditional Chinese Medicine
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Although the global vascular surgeons have made significant progress in the study of RFA in the treatment of VVs, there are still many unknown areas to be explored, and the current research mainly focuses on the surgical effect of RFA and related complications, while the research on intraoperative pain is relatively scarce.
First of all, RFA does not have a clear definition of intraoperative pain in the treatment of varicose veins of the lower extremities, so it has not received enough attention in clinical practice, and many doctors regard the success of surgery as the end point of treatment, but ignore the impact of intraoperative pain on the patient's surgical experience.
In addition, with the continuous progress of varicose vein surgery of the lower extremities, the anesthesia method has also changed from general anesthesia to combined spinal-epidural block to today's local anesthesia, the swollen anesthetic solution is the main anesthetic drug used in RFA surgery, and the infiltration of the swollen anesthetic fluid around the saphenous vein is the key to the success of RFA, but paradoxically, this is also the most intense part of the patient's pain, the swollen fluid is usually a crystalloid solution containing local anesthetic and epinephrine, which is acidic in nature, which is also the main reason for the "tingling" during skin infiltration , A Cochrane review noted that adjusting the pH of lidocaine solution by adding sodium bicarbonate significantly reduced the pain reported on a 10 cm visual analogue scale (VAS) during skin infiltration, and that the temperature of the swollen anesthetic solution also had an effect on pain during skin infiltration, Bell et al. and Alonso et al.
In a prospective randomized controlled trial, it was found that heating the local anesthetic solution to 37°C and 42°C reduced pain sensation, and heating the local anesthetic solution containing epinephrine to near body temperature was effective in reducing the pain of local anesthetic infiltration in patients, however, in a randomized clinical trial in 2018, patients were divided into cold swollen fluid group (4 °C) and room temperature swollen fluid group (24 °C), and the authors found that patients in the cold swollen fluid group had less pain during and after RFA, The amount of postoperative analgesics was significantly reduced.
Therefore, the patient's pain during RFA has become a problem that we must pay attention to, and the operator should pay attention to the details and pay attention to the patient's intraoperative condition during RFA, so as to reduce the patient's intraoperative pain and give the patient a better surgical experience.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
155
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Sichuan
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Chengdu, Sichuan, China, 610000
- Hospital of Chengdu University of Traditional Chinese Medicine
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
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
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Puncture catheterization
Zeitfenster: At the time of surgery
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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
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At the time of surgery
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Inject swollen fluid
Zeitfenster: At the time of surgery
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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
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At the time of surgery
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol. 2007 Sep;1(5):725-9. doi: 10.1177/193229680700100517.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juli 2024
Primärer Abschluss (Tatsächlich)
1. September 2024
Studienabschluss (Tatsächlich)
1. September 2024
Studienanmeldedaten
Zuerst eingereicht
29. Juli 2024
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Juni 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Juni 2026
Zuletzt verifiziert
1. Juli 2024
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- chengduUTCMvs6
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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