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

Authors Lee SO, Huang LP, Wong CS

Received 28 May 2020

Accepted for publication 20 August 2020

Published 9 September 2020 Volume 2020:13 Pages 2247—2253

DOI https://doi.org/10.2147/JPR.S263315

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr E Alfonso Romero-Sandoval


Sing-Ong Lee,1 Li-Ping Huang,1 Chih-Shung Wong1– 3

1Department of Anesthesiology, Cathay General Hospital, Taipei, Taiwan; 2Graduate Institute of Medical Science, National Defense Medical Center, Taipei, Taiwan; 3School of Medicine, Fu-Jen Catholic University, New Taipei, Taiwan

Correspondence: Chih-Shung Wong Department of Anesthesiology
Cathay General Hospital, #280, Renai Road, Section 4, Taipei, Taiwan
Tel +886-2-27082121 Ext 3510
Fax +886-2-87924835
Email w82556@gmail.com

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.

Keywords: nalbuphine, enhanced recovery after surgery, multimodal analgesia, preventive analgesia

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