Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia

Yeh, Chien-Yuh; Jao, Shu-Wen; Chen, Jinn‐Shiun; Fan, Chung-Wei; Chen, Hong‐Hwa; Hsieh, Pao-Shiu; Wu, Chang‐Chieh; Lee, Chia-Cheng; Kuo, Yuan-Hung; Hsieh, Meng‐Che; Huang, Wen‐Shih; Chung, Yuan‐Chiang; Liou, Tian-Yuh; Chiu, Hsi-Hsiung; Tseng, Wen-Ko; Lee, Ko‐Chao; Wang, Jeng‐Yi

doi:10.1097/ajp.0000000000000417

Cited by 20 publications

(31 citation statements)

References 31 publications

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“…However, our findings contradict those in a previous report in which preoperative injection of DS was associated with a superior level of pain reduction and use of fewer rescue analgesics compared to placebo in patients undergoing hemorrhoidectomy. 13 When analyzing outcomes from these two studies, there are important differences that provide clarification. First, the magnitude of postoperative acute pain after LC was much lower (minimum to maximum range: 0.8–1.5) than that associated with hemorrhoidectomy (minimum to maximum range: 2.4~5.4) during the first day after surgery; 17 , 21 as such, the absolute magnitude of pain reduction associated with DS administration was more difficult to evaluate in our study.…”

Section: Discussionmentioning

confidence: 99%

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

Lee

Huang

Wong

2020

JPR

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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.

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Section: Discussionmentioning

confidence: 99%

“…Previous studies have revealed that pre-operative administration of DS resulted in effective pain control for 7 days and was associated with a significant reduction in postoperative ketorolac consumption after hemorrhoidectomy. 13 …”

Section: Introductionmentioning

confidence: 99%

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

Lee

Huang

Wong

2020

JPR

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“…Assuming an equivalence margin of 10 and a standard deviation of 18 [11], 104 patients were required to achieve the power of 80% by the non-inferiority test with a one-sided 97.5% confidence interval (CI), which was equivalent to a two-sided 95% CI. Considering a 5% dropout rate, a total sample size of 110 (55 per arm) patients were planned to be randomly assigned to the treatment groups at a 1:1 ratio.…”

Section: Methodsmentioning

confidence: 99%

“…ERDS can rapidly hydrolyze to nalbuphine by esterases in the human bloodstream [ 10 ]. A randomized study has reported that pre-operative intramuscular administration of ERDS exhibits a well-tolerated safety profile and weekly analgesic effect, less post-operative analgesics use, and prolonged time to the first use of analgesics in patients undergoing hemorrhoidectomy [ 11 ]. In addition, ERDS contributes a relatively low concentration of nalbuphine acting on the CNS, which served as background analgesia, but also helps to prevent MOR agonist-induced side effects such as pruritus, nausea, and vomiting [ 12 – 14 ].…”

Section: Introductionmentioning

confidence: 99%

Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial

Chang

Huang

et al. 2020

Pain Ther

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Introduction: Post-operative pain control remains unsatisfactory in patients after laparotomy. This study aimed to evaluate the efficacy, safety, and quality of life with a single dose of extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl in patients undergoing laparotomy. Methods: This was a prospective, open-label, randomized controlled study. Of 110 randomized patients, 107 completed all assessments. The area under the curve (AUC) of visual analogue scale (VAS) from baseline to 48 h after surgery, VAS throughout 7 days after surgery, post-operative analgesics use, quality of life, satisfaction, and safety were evaluated.

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“…The no observed adverse effect level is considered to be less than 30 mg/kg in dogs. In humans, several clinical studies have been conducted to investigate the pharmacokinetics, bioavailability [6–8], efficacy, and safety of Naldebain ® . The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain ® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief.…”

Section: Introductionmentioning

confidence: 99%

Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial

Tsai

Chang

et al. 2019

Trials

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BackgroundA long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain® (nalbuphine sebacate) has been developed as a new premedication for postoperative pain management. The primary objective of this study is to determine the efficacy and safety of a single dose of intramuscular Naldebain® in patients scheduled to undergo elective laparotomy.Methods/designA total of 110 patients will be recruited and randomized into two treatment groups. Group 1 receives a single dose of Naldebain® intramuscularly 24 ± 12 h prior to surgery. Group 2 receives intravenous patient-controlled analgesia (PCA) with fentanyl through 48 h postsurgery. Both groups will have follow-up observations until the final visit (day of discharge, day 6–30). The primary efficacy endpoint is to assess time-specific pain intensity calculated as the area under the curve (AUC) of a visual analog scale at individual time points and by using total AUC. Safety endpoints—including incidence of treatment, emergent adverse events, and percentage of abnormality from baseline to final visit—in vital signs, laboratory tests, and injection site evaluations will also be analyzed. Statistical analyses will be performed on the data to compare the two groups.DiscussionPost-laparotomy pain can have a harmful effect on patient recovery; therefore, a slow-release formulation that can cover at least 7 days of analgesic effect is required. This study will demonstrate whether a single use of Naldebain® is not less efficacious than PCA with fentanyl for pain management as a non-inferior trial.Trial registrationNCT03296488.Electronic supplementary materialThe online version of this article (10.1186/s13063-019-3260-4) contains supplementary material, which is available to authorized users.

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Sebacoyl Dinalbuphine Ester Extended-release Injection for Long-acting Analgesia

Abstract: SDE injection demonstrated an extended analgesia effect, with a statistically significant reduction in pain intensity through 48 hours and 7 days after hemorrhoidectomy.

Cited by 20 publications

References 31 publications

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

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

Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial

Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial

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