ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The µ-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy.

Background:Pain management with conventional opioids can be challenging due to dose-limiting adverse events (AEs), some of which may be related to the simultaneous activation of β-arrestin (a signaling pathway associated with opioid-related AEs) and G-protein pathways. The investigational analgesic oliceridine is a G-protein-selective agonist at the µ-opioid receptor with less recruitment of β-arrestin. The objective of this phase 3, open-label, multi-center study was to evaluate the safety and tolerability, of IV oliceridine for moderate to severe acute pain in a broad, real-world patient population, including postoperative surgical patients and non-surgical patients with painful medical conditions. Methods:Adult patients with a score ≥4 on 11-point NRS for pain intensity received IV oliceridine either by bolus or PCA; multimodal analgesia was permitted. Safety was assessed using AE reports, study discontinuations, clinical laboratory and vital sign measures. Results:A total of 768 patients received oliceridine. The mean age (SD) was 54.1 (16.1) years, with 32% ≥65 years of age. Most patients were female (65%) and Caucasian (78%). Surgical patients comprised the majority of the study population (94%), most common being orthopedic (30%), colorectal (15%) or gynecologic (15%) procedures. Multimodal analgesia was administered to 84% of patients. Oliceridine provided a rapid reduction in NRS pain score by 2.2 ± 2.3 at 30 mins from a score of 6.3 ± 2.1 (at baseline) which was maintained to the end of treatment. No deaths or significant cardiorespiratory events were reported. The incidence of AEs leading to early discontinuation and serious AEs were 2% and 3%, respectively. Nausea (31%), constipation (11%), and vomiting (10%) were the most common AEs. AEs were mostly of mild (37%) or moderate (25%) severity and considered possibly or probably related to oliceridine in 33% of patients. Conclusion:Oliceridine IV for the management of moderate to severe acute pain was generally safe and well tolerated in the patients studied. ClinicalTrialsgov identifier:NCT02656875

Managing Opioid-Tolerant Patients in the Perioperative Surgical Home.

Management of acute postoperative pain is important to decrease perioperative morbidity and improve patient satisfaction. Opioids are associated with potential adverse events that may lead to significant risk. Uncontrolled pain is a risk factor in the transformation of acute pain to chronic pain. Balancing these issues can be especially challenging in opioid-tolerant patients undergoing surgery, for whom rapidly escalating opioid doses in an effort to control pain can be associated with increased complications. In the perioperative surgical home model, anesthesiologists are positioned to coordinate a comprehensive perioperative analgesic plan that begins with the preoperative assessment and continues through discharge

Conservative management of low back pain

Back pain is prevalent worldwide, but back pain disability has reached epidemic proportions in many industrialised societies. Few patients have serious medical pathology or direct neurological involvement requiring surgery. Although the causes remain unclear, physical stress and its consequences on discs, facet joints and supporting soft tissues at work or leisure are important, sometimes aggravated by adverse psychosocial factors. Modern management emphasises the role of self-care, beginning in primary care with the first episode. Without root compression, bed rest should not exceed 48 hours. Emphasis is on encouraging a rapid return to physical fitness and other activities, including employment, acknowledging that returning to a normal life may require working through pain. Medication facilitates this. No one should remain in pain beyond six weeks without being referred to a specialist service for a physical and psychosocial assessment by appropriately trained professionals and with consultant support for investigation, pain management and rehabilitation when needed

A survey of health care models that encompass multiple departments

In this survey we review quantitative health care models to illustrate the extent to which they encompass multiple hospital departments. The paper provides general overviews of the relationships that exists between major hospital departments and describes how these relationships are accounted for by researchers. We find the atomistic view of hospitals often taken by researchers is partially due to the ambiguity of patient care trajectories. To this end clinical pathways literature is reviewed to illustrate its potential for clarifying patient flows and for providing a holistic hospital perspective

Taxonomic classification of planning decisions in health care: a review of the state of the art in OR/MS

We provide a structured overview of the typical decisions to be made in resource capacity planning and control in health care, and a review of relevant OR/MS articles for each planning decision. The contribution of this paper is twofold. First, to position the planning decisions, a taxonomy is presented. This taxonomy provides health care managers and OR/MS researchers with a method to identify, break down and classify planning and control decisions. Second, following the taxonomy, for six health care services, we provide an exhaustive specification of planning and control decisions in resource capacity planning and control. For each planning and control decision, we structurally review the key OR/MS articles and the OR/MS methods and techniques that are applied in the literature to support decision making

"Specials" manufacture in the N.H.S.

Over the past 30 years there has been a vast change in the manufacture of "specials" within the National Health Service. From being primitive, badly equipped units situated in the basement of nearly all hospitals, N.H.S. production units have changed to purpose built, hi-tech units licensed by the Medicines Control Agency, providing a fast, efficient and validated "specials" service. Although non-profit making organisations, N.H.S. Production units have to be self-financing. Thus staff costs, overheads and replacement of equipment must be financed by sales. Production pharmacists in the N.H.S. are now working together to rationalise the product list within their units. Certain units have taken over the role of national supplier for items and instead of duplicating effort, other units will buy from them.peer-reviewe

Efeitos de Anestésico Local no Tempo Entre Bólus e na Duração do Trabalho de Parto em Patient-Controlled Epidural Analgesia: Estudo Prospectivo de Dois Regimes de Doses Ultra-Baixas com Ropivacaina e Sufentanil

BACKGROUND: Patient-controlled epidural analgesia with low concentrations of anesthetics is effective in reducing labor pain. The aim of this study was to assess and compare two ultra-low dose regimens of ropivacaine and sufentanil (0.1% ropivacaine plus 0.5 μg.ml-1 sufentanil vs. 0.06% ropivacaine plus 0.5 μg.ml-1 sufentanil) on the intervals between boluses and the duration of labor. MATERIAL AND METHODS: In this non-randomized prospective study, conducted between January and July 2010, two groups of parturients received patient-controlled epidural analgesia: Group I (n = 58; 1 mg.ml-1 ropivacaine + 0.5 μg.ml-1 sufentanil) and Group II (n = 57; 0.6 mg.ml-1 ropivacaine + 0.5 μg.ml-1 sufentanil). Rescue doses of ropivacaine at the concentration of the assigned group without sufentanil were administered as necessary. Pain, local anesthetic requirements, neuraxial blockade characteristics, labor and neonatal outcomes, and maternal satisfaction were recorded. RESULTS: The ropivacaine dose was greater in Group I (9.5 [7.7-12.7] mg.h-1 vs. 6.1 [5.1-9.8 mg.h-1], p < 0.001). A time increase between each bolus was observed in Group I (beta = 32.61 min, 95% CI [25.39; 39.82], p < 0.001), whereas a time decrease was observed in Group II (beta = -1.40 min, 95% CI [-2.44; -0.36], p = 0.009). The duration of the second stage of labor in Group I was significantly longer than that in Group II (78 min vs. 65 min, p < 0.001). CONCLUSIONS: Parturients receiving 0.06% ropivacaine exhibited less evidence of cumulative effects and exhibited faster second stage progression than those who received 0.1% ropivacaine