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      Preoperative Administration of Extended-Release Dinalbuphine Sebacate Compares with Morphine for Post-Laparoscopic Cholecystectomy Pain Management: A Randomized Study

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          Perioperative pain management plays a critical role in the effort to promote enhanced recovery after surgery (ERAS). Pain is also the most concern for patients after laparoscopic cholecystectomy (LC). Naldebain (extended-release dinalbuphine sebacate, DS) is an oil-based formulation for intramuscular injection that has been designed for extended release and can be used for preoperative analgesia over a 7-day period. This study was aimed to compare the efficacy of DS injection with that of regular postoperative morphine administered when necessary for the management of post-laparoscopic cholecystectomy pain.

          Patients and Methods

          Forty-four patients scheduled for elective laparoscopic cholecystectomy were included in this prospective study. The patients were allocated randomly into two groups, with equal numbers receiving preoperative DS versus post-operative morphine. A total of 21 and 22 patients completed the study within the preoperative DS and post-operative morphine group, respectively.


          There were no statistically significant differences between two treatment groups with respect to length of surgery, anesthetics used during operation, or the average visual analog scale pain score in the post-operative anesthesia care unit (PACU), and at 4, 24, 48, and 72 hours post-procedure. Morphine was required only during the first postoperative day among those in the DS group. Safety was comparable in both DS and morphine groups.


          A single preoperative dose of DS provides sufficient analgesia along with a manageable safety profile and no interference with surgical anesthetics when compared to control cases that underwent surgery without preoperative DS treatment. This pilot study suggests that preoperative administration of DS is safe and may decrease the need for postoperative opioid use after laparoscopic cholecystectomy.


          ClinicalTrials.gov Identifier: NCT03713216.

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          Most cited references 25

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          A qualitative and quantitative systematic review of preemptive analgesia for postoperative pain relief: the role of timing of analgesia.

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            Postoperative pain control.

            The effective relief of pain is of the utmost importance to anyone treating patients undergoing surgery. Pain relief has significant physiological benefits; hence, monitoring of pain relief is increasingly becoming an important postoperative quality measure. The goal for postoperative pain management is to reduce or eliminate pain and discomfort with a minimum of side effects. Various agents (opioid vs. nonopioid), routes (oral, intravenous, neuraxial, regional) and modes (patient controlled vs. "as needed") for the treatment of postoperative pain exist. Although traditionally the mainstay of postoperative analgesia is opioid based, increasingly more evidence exists to support a multimodal approach with the intent to reduce opioid side effects (such as nausea and ileus) and improve pain scores. Enhanced recovery protocols to reduce length of stay in colorectal surgery are becoming more prevalent and include multimodal opioid sparing regimens as a critical component. Familiarity with the efficacy of available agents and routes of administration is important to tailor the postoperative regimen to the needs of the individual patient.
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              Analgesic treatment after laparoscopic cholecystectomy: a critical assessment of the evidence.

               Thue Bisgaard (2006)
              Acute pain after laparoscopic cholecystectomy is complex in nature. The pain pattern does not resemble pain after other laparoscopic procedures, suggesting that analgesic treatment might be procedure specific and multimodal. Randomized trials of analgesia after laparoscopic cholecystectomy were identified by systematic electronic literature searches (1985 to June 2005) supplemented with manual searching. The trials were categorized by well-defined criteria into high, moderate, or poor methodologic quality. Conclusions were based on trials of high and moderate methodologic quality. In total, 64 randomized analgesic trials were identified, comprising a total of 5,018 evaluated patients. The literature suggests a multimodal analgesic regimen consisting of a preoperative single dose of dexamethasone, incisional local anesthetics (at the beginning or at the end of surgery, depending on preference), and continuous treatment with nonsteroidal antiinflammatory drugs (or cyclooxygenase-2 inhibitors) during the first 3-4 days. Opioids should be used only when other analgesic techniques fail.

                Author and article information

                J Pain Res
                J Pain Res
                Journal of Pain Research
                09 September 2020
                : 13
                : 2247-2253
                [1 ]Department of Anesthesiology, Cathay General Hospital , Taipei, Taiwan
                [2 ]Graduate Institute of Medical Science, National Defense Medical Center , Taipei, Taiwan
                [3 ]School of Medicine, Fu-Jen Catholic University , New Taipei, Taiwan
                Author notes
                Correspondence: Chih-Shung Wong Department of Anesthesiology, Cathay General Hospital , #280, Renai Road, Section 4, Taipei, TaiwanTel +886-2-27082121 Ext 3510Fax +886-2-87924835 Email w82556@gmail.com
                © 2020 Lee et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 2, Tables: 9, References: 33, Pages: 7
                The authors have no sources of funding to declare for this manuscript.
                Clinical Trial Report


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