VASA. Zeitschrift für Gefässkrankheiten
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Randomized Controlled Trial Observational Study
The influence of continuous local wound infusion on postoperative pain in patients undergoing transfemoral amputation.
This pilot study was set up to examine the effects of a continuous postoperative wound infusion system with a local anaesthetic on perioperative pain and the consumption of analgesics. ⋯ Continuous postoperative wound infusion with a local anaesthetic in combination with a standard pain management protocol can reduce both stump pain and opiate intake in patients who have undergone transfemoral amputation. Phantom pain was not significantly affected.
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Randomized Controlled Trial Multicenter Study
Design and rationale of a randomized, double-blind, placebo-controlled phase III study for autologous bone marrow cell transplantation in critical limb ischemia: the BONe Marrow Outcomes Trial in Critical Limb Ischemia (BONMOT-CLI).
Critical limb ischemia (CLI) is the end-stage of peripheral artery disease. Only about two thirds of patients with CLI can be revascularised, one third progresses to leg amputation with high associated morbidity and mortality. Therapeutic angiogenesis with bone marrow cells has shown promising improvement in less severe stages of peripheral ischemia. Our study evaluates the therapeutic value of bone marrow cell induced angiogenesis and arteriogenesis in severe, limb-threatening ischemia. ⋯ The results of this first randomized placebo-controlled trial for autologous bone marrow cell therapy in CLI will clarify the value of this new therapeutic modality in a patient population with no other alternatives except major amputation.
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Randomized Controlled Trial Clinical Trial
Thrombophlebitis associated with intravenous injection anaesthetics: influence of arm positioning.
Thrombophlebitis (TP) is a frequent complication of the intravenous application of injection anaesthetics. We investigated the influence of different arm positions on the incidence of such a complication in patients undergoing shoulder arthroscopy. ⋯ An elevated position of the arm used for anaesthesia during shoulder arthroscopy is suggested in order to prevent TP.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Low-dose iloprost infusions compared to the standard dose in patients with peripheral arterial occlusive disease Fontaine stage IV. DAWID Study Group.
Intravenous iloprost, titrated from 0.5 up to 2.0 ng/kg/min has been shown in patients with PAOD III/IV to significantly improve healing of trophic lesions, relief of rest pain, and reduce the rate of major amputation or death at 6 months as compared to placebo. The effect is considered related to improvement of the microcirculation. The aim of the present trial was to identify an optimum dose regarding treatment response and tolerability, by studying 4 doses of 25, 50, 75 and 100 micrograms iloprost daily. ⋯ It is concluded that iloprost should be titrated to the optimum rather than maximum tolerated dose, since a higher incidence of side effects not associated with an increased treatment response was observed at higher doses.
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Randomized Controlled Trial Clinical Trial
[Prostacyclin (iloprost) as an adjuvant in local surgical therapy of stage IV arterial occlusive disease--is quantification of the therapeutic effect possible with tcPO2 measurements?].
The effect of intravenous therapy with iloprost (average duration 6 weeks) on the prognosis of leg-preserving local surgical treatment and on the transcutaneously measured oxygen pressure (tcPO2) in patients with ischaemic lesions was investigated in a prospective, open, controlled, randomized study. All of the 30 patients recruited to the study suffered from a peripheral arterial occlusive disease Fontaine stage IV with progressive symptoms and arterial occlusions below the knee. 15 patients received iloprost intravenously for 6 hours per day in an individual tolerable dose (mean dose: 1.7 ng/kg/min). 15 patients in the control group received no trial therapy. During the treatment period each patient underwent minor amputation or skin grafting. ⋯ At the same time a significant difference in the tcPO2-changes between responders and nonresponders was demonstrated (p < 0.05). Patients with primary wound healing had a greater increase in tcPO2 than patients whose wounds did not heal. An increase of at least 10 mmHg (6 patients) in tcPO2 during the infusion after 3 weeks of therapy predicted primary post-operative wound healing.