RCT of Buffered Tumescent Anaesthesia for EVLA

• Research type

  Research Study

• Full title

  Tumescent Anaesthesia in Endovenous Laser Ablation of Varicose Veins: A Randomised Controlled Trial of a Buffered Tumescent Solution

• IRAS ID

  80130

• Contact name

  Tom Wallace

• Eudract number

  2011-005575-16

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The traditional method of treating varicose veins is a surgical operation whereby an incision is made in the groin with the patient asleep under a general anaesthetic. A newer method of treating varicose veins is less invasive than traditional surgery and can be performed under local anaesthetic. It involves passing a fine wire into the affected vein, which then applies heat to seal off the vein. This is known as ??endovenous thermal ablation?. After the vein has been heated in this way, it then essentially dissolves over time. The most established method of this kind of treatment is Endovenous Laser Ablation (EVLA), which uses a laser beam fired within the vein. Evidence from many institutions, including our own, shows that EVLA offers a number benefits over surgery in terms of less pain, quicker improvement in quality of life and return to full activities or work. At 5 years only 1 in 20 patients have any evidence of their varicose veins returning. The technique of EVLA has been refined over the last few years, having already been shown to be safe and effective. In our experience, the most uncomfortable part of the EVLA procedure is the injection of local anaesthetic around the vein. This research study aims to find out whether a modification of the constituents within the anaesthetic solution can improve its tolerability to patients, and whether this might have any longer lasting effects in terms of pain, quality of life and return to normal activities. Patients with varicose veins who are due to undergo EVLA will be invited to take part in the study. Those who agree to take part will be randomly allocated to receive either the standard anaesthetic or the modified form. Participants will then be asked to complete questionnaires regarding pain and quality of life.

• REC name

  North East - York Research Ethics Committee

• REC reference

  11/NE/0363

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Favourable Opinion