Abstract | BACKGROUND: The benefit-risk ratio of extended fondaparinux therapy has not been assessed in patients undergoing major lower limb joint arthroplasty. Few data on the concomitant use of fondaparinux and continuous neuraxial or deep peripheral nerve blockade are available. We performed a prospective intervention study in patients undergoing major orthopedic surgery primarily designed to assess the efficacy of fondaparinux when drug administration was withheld for 48 h to permit removal of a neuraxial or deep peripheral nerve catheter. The safety and efficacy of extended fondaparinux therapy for the prevention of venous thromboembolism were also evaluated. METHODS: RESULTS: We recruited 5704 patients. A neuraxial or deep peripheral nerve catheter was inserted in 1553 (27%) patients and 78 (1.4%) patients, respectively. The rate of venous thromboembolism was 1.0% (54 of 5387). There was no difference between patients without (1.1%) or with (0.8%) a catheter (the upper limit of the 95% confidence interval of the odds ratio, 1.49, being below the predetermined noninferiority margin of 1.75). The incidence of major bleeding was 0.8% (42 of 5382). No neuraxial or perineural hematoma was reported. CONCLUSIONS:
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Authors | François J Singelyn, Cees C P M Verheyen, Franco Piovella, Hugo K Van Aken, Nadia Rosencher, EXPERT Study Investigators |
Journal | Anesthesia and analgesia
(Anesth Analg)
Vol. 105
Issue 6
Pg. 1540-7, table of contents
(Dec 2007)
ISSN: 1526-7598 [Electronic] United States |
PMID | 18042845
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Polysaccharides
- Fondaparinux
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Topics |
- Aged
- Catheterization
(adverse effects, methods)
- Female
- Fondaparinux
- Humans
- Internationality
- Lower Extremity
(physiology, surgery)
- Male
- Middle Aged
- Orthopedic Procedures
(adverse effects, methods)
- Peripheral Nerves
(physiology)
- Polysaccharides
(administration & dosage, adverse effects)
- Postoperative Complications
(etiology, prevention & control)
- Prospective Studies
- Thrombolytic Therapy
(adverse effects, methods)
- Time Factors
- Venous Thrombosis
(etiology, prevention & control)
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