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      The pharmacokinetics and safety of an intraoperative bupivacaine-collagen implant (XaraColl ®) for postoperative analgesia in women following total abdominal hysterectomy

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          Abstract

          Background

          XaraColl ®, a collagen-based intraoperative implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. We examined the pharmacokinetics, safety and efficacy of XaraColl following implantation in women undergoing total abdominal hysterectomy.

          Methods

          Three XaraColl implants, each containing 50 mg bupivacaine hydrochloride, were implanted in 12 women undergoing total abdominal hysterectomy for a benign condition. Serum samples were obtained through 96 hours for pharmacokinetic analysis. Patients received acetaminophen 1000 mg every 6 hours, diclofenac 50 mg every 8 hours, and were given access to intravenous morphine for breakthrough pain via patient-controlled analgesia during the first 24 hours. Pain intensity was assessed at regular intervals using a 100 mm visual analog scale. Safety was assessed through 30 days.

          Results

          The pharmacokinetic profile displayed a double peak in bupivacaine concentration with the second peak occurring up to 24 hours after the first and at a generally higher concentration. The time to maximum concentration (t max) varied from 0.5 to 24 hours (median 12 hours) according to which peak predominated. The mean maximum concentration (C max) was 0.22 μg/mL and the maximum individual C max was 0.44 μg/mL, which are well below the established systemic toxicity threshold. Morphine use was generally low (mean 16.8 mg; median 6.5 mg) and compared favorably with institutional experience. At 6 hours post-surgery, 11 patients recorded pain scores ≤ 20 mm, 6 recorded ≤ 10 mm, and 2 reported no pain. Scores continued to decline throughout the study. The product was considered safe and well tolerated.

          Conclusion

          XaraColl exhibits a biphasic and sustained release profile that may provide a significant advance over standard wound infiltration. Considering the encouraging results from this study alongside those from other randomized controlled efficacy trials, XaraColl should be further evaluated as a postoperative analgesic in large, double-blind efficacy trials.

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          Most cited references 26

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          Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged.

          Postoperative pain can have a significant effect on patient recovery. An understanding of patient attitudes and concerns about postoperative pain is important for identifying ways health care professionals can improve postoperative care. To assess patients' postoperative pain experience and the status of acute pain management, we conducted a national study by using telephone questionnaires. A random sample of 250 adults who had undergone surgical procedures recently in the United States was obtained from National Family Opinion. Patients were asked about the severity of postsurgical pain, treatment, satisfaction with pain medication, patient education, and perceptions about postoperative pain and pain medications. Approximately 80% of patients experienced acute pain after surgery. Of these patients, 86% had moderate, severe, or extreme pain, with more patients experiencing pain after discharge than before discharge. Experiencing postoperative pain was the most common concern (59%) of patients. Almost 25% of patients who received pain medications experienced adverse effects; however, almost 90% of them were satisfied with their pain medications. Approximately two thirds of patients reported that a health care professional talked with them about their pain. Despite an increased focus on pain management programs and the development of new standards for pain management, many patients continue to experience intense pain after surgery. Additional efforts are required to improve patients' postoperative pain experience. A survey of 250 US adults who had undergone a recent surgical procedure asked about their postoperative pain experience. Approximately 80% of patients experienced pain after surgery. Of these patients, 86% had moderate, severe, or extreme pain. Additional efforts are required to improve patients' postoperative pain experience.
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            Treatment of acute postoperative pain.

            Although postoperative pain remains incompletely controlled in some settings, increased understanding of its mechanisms and the development of several therapeutic approaches have substantially improved pain control in past years. Advances in our understanding of the process of nociception have led to insight into gene-based pain therapy, the development of acute opioid-induced hyperalgesia, and persistent postsurgical pain. Use of specific analgesic techniques such as regional analgesia could improve patient outcomes. We also examine the development of new analgesic agents and treatment modalities and regimens for acute postoperative pain. Copyright © 2011 Elsevier Ltd. All rights reserved.
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              Improving postoperative pain management: what are the unresolved issues?

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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2013
                04 March 2013
                : 6
                : 151-159
                Affiliations
                [1 ]Cusack Pharmaceutical Consulting, Burlington, NJ, USA
                [2 ]Departments of Gynaecology and Anaesthetics, Wexham Park Hospital, Slough, UK
                [3 ]Innocoll Technologies, Athlone, Ireland
                Author notes
                Correspondence: Susan L Cusack Cusack Pharmaceutical Consulting, 1 Gate Court Burlington, NJ 08016, USA Tel/Fax +1 609 387 7733 Email susancusack1@ 123456comcast.net0
                Article
                jpr-6-151
                10.2147/JPR.S40976
                3594918
                23503706
                © 2013 Cusack et al, publisher and licensee Dove Medical Press Ltd

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Original Research

                Anesthesiology & Pain management

                anesthetic, analgesia, opioid use, pain

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