A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol.

INTRODUCTION: Deep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the most common causes of DVO. Conventional treatment of DVO focuses on reducing pain or leg swelling by use of (pain) medication and therapeutic elastic stockings. In the past, a venous bypass was offered in severe post-thrombotic cases, but this procedure showed bad clinical and patency outcomes. With the introduction of percutaneous angioplasty and dedicated venous stents new opportunities were created. Deep venous stenting has been shown to be effective in retrospective case series. However, there is no prior research in which QoL after interventional treatment is compared with QoL after conventional treatment. Currently, there is a debate about the true additional value of interventional treatment. We investigate whether those patients who are treated with stenting experience a change in short form 36 (SF-36) and the Veines-QoL/Sym questionnaires compared with conventionally treated patients. METHODS AND ANALYSIS: This is a randomised trial comparing conservative deep venous management to interventional treatment. A total of 130 patients with post-thrombotic syndrome (PTS) or MTS, eligible for interventional percutaneous treatment, who did not have previous deep venous intervention will be included. Patients will be randomised to conservative treatment or venous stenting and stratified for the PTS or MTS subgroup. Conservative treatment consists of either one or a combination of pain medications, manual lymphatic drainage, compression stockings and regular post-thrombotic anticoagulant therapy.The primary outcome is the QoL change after 12 months compared with baseline QoL. Secondary outcomes are QoL changes at 6 weeks, clinical assessment of DVO, recurrence rate of deep venous thrombosis at 6 weeks and 12 months, and the total amount of working days lost. Intervention-specific outcomes include complications and patency. ETHICS AND DISSEMINATION: The protocol is approved by the Medical Ethics Committee of Academisch ziekenhuis Maastricht/Universiteit Maastricht, The Netherlands (protocol number NLNL55641.068.15 / METC 161008).We aim to publish the results of this study in a peer reviewed journal and present our findings at national or international conferences. TRIAL REGISTRATION NUMBER: The study protocol was registered at www.clinicaltrials.gov (registration number: NCT03026049) on 17 January 2017.

Prospective study of a single treatment strategy for local tumescent anesthesia in Muller phlebectomy.

BACKGROUND: Ambulatory Muller phlebectomy for varicose veins can be performed under local anesthesia. However, subcutaneous injection of local tumescent anesthetics may cause discomfort because of acidity of the solution. Addition of sodium bicarbonate lowers the acidity of anesthetic solutions, which might cause less pain. The objective of this study was to study whether alkalinization of the local anesthetic solution with sodium bicarbonate 1.4% decreases perioperative pain during Muller phlebectomies. METHODS: It is a double-blind single-center randomized controlled trial. In all, 101 patients scheduled for ambulatory Muller phlebectomy were randomized to receive either local anesthesia with alkalinized solution (lidocaine 1% and epinephrine in sodium bicarbonate 1.4%) or standard solution (lidocaine 1% and epinephrine in saline 0.9%). Primary outcome was pain during injection of local anesthetics with the use of the Visual Analogue Scale (VAS). Secondary outcomes were peroperative and postoperative pain, use of analgesics, patient satisfaction, return to function, and complications. RESULTS: Patients receiving subcutaneous injection of local anesthetics diluted in sodium bicarbonate 1.4% experienced significantly less pain during injection compared with patients treated with standard anesthetic solution (VAS, 1.75 ± 1.8 vs. 3.55 ± 2.2, P < 0.00). Peroperative and postoperative pain, complication rates, use of analgesics, patient satisfaction, return to function, and complications did not differ between the 2 groups (P > 0.10). CONCLUSIONS: Alkalinization of local anesthetic solution with sodium bicarbonate 1.4% significantly improves patient comfort during injection of local tumescent anesthesia.