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

Abstract

Purpose 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. Results 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. Conclusion 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. Registration ClinicalTrials.gov Identifier: NCT03713216.

Comparison of the Efficacy and Safety of Dinalbuphine Sebacate, Patient-Controlled Analgesia, and Conventional Analgesia After Laparotomy for Gynecologic Cancers: A Retrospective Study

“…It has shown benefits of less postoperative analgesic consumption and sufficient efficacy in POP pain intensity management. 12 , 16 , 17 …”

Multimodal Analgesia With Long-Acting Dinalbuphine Sebacate Plus Transversus Abdominis Plane Block for Perioperative Pain Management in Bariatric Surgery: A Case Report

“…DS (Naldebain ® Injection, Lumosa Therapeutics, Taiwan) was introduced in Taiwan in 2017; it, via intramuscular injection, delivers and maintains an effective nalbuphine analgesic blood level for approximately 7 days (Huang et al, 2020). Our previous study showed DS provided satisfying postoperative pain relief for laparoscopic cholecystectomy (Lee et al, 2020). The postoperative pain scores of laparoscopic bariatric surgery are variable from 6 to 8 out of 10 ( Gerbershagen et al, 2013;Brummett et al, 2017).…”

“…DS is an extended-release prodrug of nalbuphine which acts as a partial agonist at the κ-opioid receptor and a weak antagonist at the µ-opioid receptor; it is slightly less potent than morphine. Compared to morphine, DS produces less dependence, less sedation, and less respiratory depression (Yeh et al, 2017;Lee et al, 2020). DS (Naldebain ® Injection, Lumosa Therapeutics, Taiwan) was introduced in Taiwan in 2017; it, via intramuscular injection, delivers and maintains an effective nalbuphine analgesic blood level for approximately 7 days (Huang et al, 2020).…”

Multimodal Analgesia with Extended-Release Dinalbuphine Sebacate for Perioperative Pain Management in Upper Extremity Trauma Surgery: A Retrospective Comparative Study

“…In addition, a previous phase III study in a population undergoing haemorrhoidectomy demonstrated that the analgesic effect of DS was capable of lasting for about 6 days [12]. The safety and efficacy of DS were also investigated with regard to post-operative pain control of several types of abdominal surgery [13][14][15].…”