Analysis of the Clinical Research Methodologies Employed During a Phrase Three Efficacy Study for Ultracet as a Post-Herniorrhaphy Analgesic




Aguilar-Zanatta, Jorge


Journal Title

Journal ISSN

Volume Title



The history of pain management stems back many thousands of years. However, not until recent times have significant advancements in biochemistry and pharmacology allowed analgesics to be incorporated in clinical interventions and everyday life. Due to these advancement, attempts to refine pharmacological action on receptors in terms of specificity would render medications with fewer side effects. The technology is present, but the application and development of modern analgesics in post-surgical settings is substandard. According to C.L. Ireson and R.W. Schwartz, (2001), the outcomes of ailment interventions in the United States are “…no better and in numerous situations worse that those achieved in other countries,” even though the United States has the most expensive healthcare in the world. Furthermore, a study performed by Carr et al. (1998), has identified the United States as demonstrating consistent inadequacies in postoperative pain management. Several factors have been identified as being contributors of poor post-surgical pain control in America. Lack of awareness of the available strategies in acute pain control and its implementation in post surgical care are labeled as being problematic observations (Puid et al., 2001). In response to these conditions as well as the managed health care time and cost limitations, new and efficacious pharmaceuticals must be made available to a broad spectrum of socio-economic strata. Currently, there is a great debate over the use of laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic procedure is more expensive and yields less postoperative pain, however the open tension free approaches are less expensive and yield more postoperative pain (Sarli et al., 2001, Medical Research Council Laparoscopic Groin Hernia Trial Group, 2001, Parviz et al., 1995). There are advantages and disadvantages to both procedures. Assuming that efficacious postoperative analgesics were available, the open tension free repair would be more feasible in terms of cost and hernia recurrence rates (Sarli et al., 2001). In terms of pharmaceutical development, the laws and guidelines by the regulatory agencies such as the Food and Drug Administration, institutional review boards, and pharmaceutical sponsor protocols must be followed. Along with good clinical practice standards, interdisciplinary collaboration in pain studies produce results that are statistically and clinically salient. The patient’s well-being and comfort is the ultimate goal in clinical pain studies and in medicine in general, therefore postoperative pain should be aggressively managed.