HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study.

BACKGROUND AND OBJECTIVES: There is a need for local anesthetics that provide consistent analgesia through 72 hours after surgery. This study evaluates the use of HTX-011 (bupivacaine and meloxicam in Biochronomerpolymer technology), an extended-release, dual-acting local anesthetic, in reducing both postoperative pain over 72 hours and postoperative opioid use when compared with bupivacaine hydrochloride (HCl) and saline placebo. Inclusion of low-dose meloxicam in HTX-011 is designed to reduce local inflammation caused by surgery, potentiating the analgesic effect of bupivacaine. Previously, significant synergy has been observed with bupivacaine and meloxicam with both given locally together. METHODS: EPOCH 1 was a randomized, double-blind, placebo-controlled and active-controlled phase III study in subjects undergoing a primary unilateral, distal, first metatarsal bunionectomy in which subjects received either a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl or saline placebo. RESULTS: A total of 412 subjects were dosed. The results for the primary and all four key secondary endpoints were statistically significant in favor of HTX-011. HTX-011 demonstrated superior, sustained pain reduction through 72 hours, significantly reduced opioid consumption and resulted in significantly more opioid-free subjects compared with saline placebo and bupivacaine HCl. Safety was similar across groups with fewer opioid-related adverse events observed in the HTX-011 group. CONCLUSIONS: HTX-011 demonstrated significant reduction in postoperative pain through 72 hours with significant reduction in opioid consumption and a significant increase in the proportion of opioid-free subjects compared with saline placebo and the most widely used local anesthetic, bupivacaine HCl. TRIAL REGISTRATION NUMBER: NCT03295721

Initial experience with magnetic resonance imaging-safe pacemakers: A review

Due of its superior soft tissue imaging capabilities, magnetic resonance imaging (MRI) has become the imaging modality of choice in many clinical situations, as illustrated by the tremendous growth in the number of MRIs performed over the past 2 decades. In parallel, the number of patients who require pacemakers or implantable cardiac defibrillators is increasing as indications for these devices broaden and the population ages. Taken together, these phenomena present an important clinical issue, as MR scans are generally contraindicated—except in urgent situations—in patients who have implanted cardiovascular devices. Potentially deleterious interactions between the magnetic fields and radio frequency (RF) energy produced by MR equipment and implantable devices have been identified, including inhibition of pacing, asynchronous/high-rate pacing, lead tip heating, and loss of capture. New devices that incorporate technologies to improve MR safety in patients with pacemakers have recently received approval in Europe and are under evaluation in the United States. Initial data from these devices suggest that these devices are safe in the MRI environment

On Symbolic Ultrametrics, Cotree Representations, and Cograph Edge Decompositions and Partitions

Symbolic ultrametrics define edge-colored complete graphs K_n and yield a simple tree representation of K_n. We discuss, under which conditions this idea can be generalized to find a symbolic ultrametric that, in addition, distinguishes between edges and non-edges of arbitrary graphs G=(V,E) and thus, yielding a simple tree representation of G. We prove that such a symbolic ultrametric can only be defined for G if and only if G is a so-called cograph. A cograph is uniquely determined by a so-called cotree. As not all graphs are cographs, we ask, furthermore, what is the minimum number of cotrees needed to represent the topology of G. The latter problem is equivalent to find an optimal cograph edge k-decomposition {E_1,...,E_k} of E so that each subgraph (V,E_i) of G is a cograph. An upper bound for the integer k is derived and it is shown that determining whether a graph has a cograph 2-decomposition, resp., 2-partition is NP-complete

Pregabalin for the treatment of postoperative pain: Results from three controlled trials using different surgical models

Conclusion: There were no significant differences between pregabalin and placebo with respect to the primary pain intensity measure in each of the three clinical trials. These studies encompass a large dataset (1,233 patients in total), and their results should be considered when assessing pregabalin’s effectiveness in postoperative pain. Further studies are required to determine the potential pain-reducing benefit of pregabalin in the postoperative setting

Testing the black disk limit in pppp collisions at very high energy

We use geometric scaling invariant quantities to measure the approach, or not, of the imaginary and real parts of the elastic scattering amplitude, to the black disk limit, in $pp$ collisions at very high energy.Comment: 11 pages, 4 figure

Разработка плана ХАССП на продукцию из дикоросов

В процессе исследования проводилось изучение документации компании, тщательное изучение технологического процесса, оценка безопасности производства продукции, определение ккт, разработка плана ХАССП. В результате исследования разработан план ХАССП на продукцию из дикоросов а именно на продукцию масло кедровое и жмых кедровый. Разработаны мероприятия для ккт.In the process of the study, the company's documentation was studied, a thorough study of the technological process, an assessment of the safety of production, the definition of the project, the development of the HACCP plan. As a result of the research, a plan of HACCP was developed for the production of wild plants, namely, the products of cedar and cedar oil. Developed activities for the book

Estimating the inelasticity with the information theory approach

Using the information theory approach, in both its extensive and nonextensive versions, we estimate the inelasticity parameter $K$ of hadronic reactions together with its distribution and energy dependence from $p\bar{p}$ and $pp$ data. We find that the inelasticity remains essentially constant in energy except for a variation around $K\sim 0.5$, as was originally expected.Comment: 14 pages, 8 figures. Misprints correcte