RCT of Surgery with tumescent anaesthesia in GSV Stripping

• Research type

  Research Study

• Full title

  A Randomised Controlled Trial of Tumescent Anaesthesia in addition to Surgical Ligation and Stripping of the Great Saphenous Vein

• IRAS ID

  78895

• Contact name

  Tom Wallace

• Sponsor organisation

  Hull & East Yorkshire Hospitals NHS Trust

• Eudract number

  2011-005574-39

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The traditional method of treating varicose veins is a surgical operation, under a general anaesthetic, to disconnect and strip out the leaking vein. Overall, varicose vein surgery is effective at improving patients?? quality of life and preventing costly complications. After the operation, patients commonly experience pain, temporary deterioration in their quality of life and take time to resume full activity. A newer method of treating varicose veins, ??endovenous thermal ablation?, is less invasive than surgery and can be performed under local anaesthetic, using heat to destroy the vein. Evidence shows that endovenous thermal ablation offers a number of benefits over surgery in terms of less pain, quicker improvement in quality of life and return to full activities. We do not know what the explanation is behind this difference, but one of the key differences in the techniques is the use of ??tumescent anaesthesia? in the endovenous procedure. This involves surrounding the vein with a solution containing local anaesthetic and adrenaline before treating it. This solution has several effects, including reducing pain and bruising. Whilst the newer minimally invasive techniques are gaining in popularity, various factors mean that they are not a treatment for everyone; many patients will still require, or prefer, the traditional surgical approach. This research study aims to find out whether the addition of this tumescent anaesthesia to the conventional surgical procedure can improve its outcomes in terms of pain, quality of life and return to normal activities. Patients undergoing surgery for varicose veins will be invited to take part in the study. Those who agree to take part will be randomly allocated to receive either the standard surgical operation or the modified procedure. 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/0362

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Favourable Opinion