AJA Asian Journal of Anesthesiology

Advancing, Capability, Improving lives

Editorial View
Volume 61, Issue 3, Pages 107-108
Chih-Shung Wong 1 , Wei-Zen Sun 2,3


Drug overdose deaths continue to be a health and societal issue in the world. US opioid epidemic report, from 1999 to 2017, found that more than 702,000 people have died from drug overdose. Drug overdose is a leading cause of injury-related death in the US in 2017. Of those deaths, almost 68% involved a prescription illicit opioid use. Therefore, US National Institutes of Health initiates the Helping to End Addiction Long-term (HEAL) program in 2018. More than 25 million adults are affected by daily pain, and 2 million individuals have an opioid use disorder (OUD) in the US, and that most of them start with opioid analgesics prescription or procured from diverted medications, once addicted, may shift to illicit heroin or synthetic opioids. The HEAL is focused on two primary aims: improving treatments for opioid misuse and addiction, and enhancing strategies for pain management; by fostering to develop novel analgesics, reducing opioids exposure, and preventing new addiction strategy. Furthermore, the inaugural national drug control strategy (NDCS), by Biden administration in 2022, addressed path forward to opioid addiction and the overdose epidemic; it signals a new direction for OUD care in US- Saving Lives is Our North Star and focuses on the OUD harm reduction practices, medications for treating OUD, and criminal justice reform to support long-term recovery of abusers and interrupt illicit drug trafficking. For those health care problems in the US, the primary goal shall be a good quality and continuity on acute pain management, particularly the perioperative pain control, instead of drug addiction therapy and justice social problems solving. The mission of the 2022 NDCS of non-opioid analgesics development guidance by U.S. Food and Drug Administration focused on three aims: development of non-opioid analgesics for acute pain, labeling claims of non-opioid analgesics to eliminate or reduce opioids use, and an expedited program for non-opioid analgesics development for acute pain management.

The ultra-restrictive opioid prescription protocol for pain management after gynecologic and abdominal surgery raised an opioid free or opioid sparing strategy for postoperative pain management to reduce opioid use and prevent chronic post-surgical pain (CPSP).1 Depending on the types of surgery, up to 70% of patients experience persisted postsurgical pain, including severe neuropathic pain and CPSP.2 Therefore, the opioid-sparing multimodal analgesia (MMA) strategy is the mainstream of enhanced recovery after surgery protocol in postoperative pain management. This issue published a guideline of Extended Release Dinalbuphine Sebacate (ERDS, Naldebain®) for perioperative pain management—“Multimodal Analgesia with Extended-Release Dinalbuphine Sebacate for Perioperative Management: Expert Opinion and Consensus.”3 ERDS is an extended-release nalbuphine, a kappa opioid receptor agonist and mu opioid receptor antagonist; it was first launched in Taiwan in 2017 and has a minimal addiction risk and is not on the controlled substance list in Taiwan.4 The analgesic effect of ERDS persists up to 7 days after intramuscular administration, covering the whole perioperative period and preventing the possibility of CPSP.5,6 In the very beginning, there were certain adverse effects and complications caused by incorrect use.7 Therefore, the use and timing of ERDS in the perioperative MMA needs a guidance for preoperative pain management by the years after clinical use experiences in Taiwan. The Taiwan Pain Society convened a working group of anesthetic and pain medicine experts. Evidence-based journal article search and review were conducted by the working group members to develop recommendations on MMA with ERDS in perioperative pain management. The working group held extensive discussions and drafted the consensus guidance for future users in using ERDS for the perioperative MMA.


Mark J, Argentieri DM, Gutierrez CA, et al.
Ultrarestrictive opioid prescription protocol for pain management after gynecologic and abdominal surgery.
JAMA Netw Open. 2018;1(8):e185452.
Richebé P, Capdevila X, Rivat C.
Persistent postsurgical pain: pathophysiology and preventative pharmacologic considerations.
Anesthesiology. 2018;129(3):590-607.
Lee SO, Lu CH, Man KM, Cheng KI, Wong CS, Sun WZ.
Multimodal analgesia with extended-release dinalbuphine sebacate for perioperative management: expert opinion and consensus.
Lumosa Therapeutics Co., Ltd.
NALDEBAIN® (Dinalbuphine Sebacate) Injection Package Insert.
Tien YE, Huang WC, Kuo HY, et al.
Pharmacokinetics of dinalbuphine sebacate and nalbuphine in human after intramuscular injection of dinalbuphine sebacate in an extended-release formulation.
Biopharm Drug Dispos. 2017;38(8):494-497.
Lee YE, Wang SY, Chen JH, et al.
Efficacy and safety of parenteral injection of an extended release κ-receptor opioid sebacoyl dinalbuphine ester for acute and chronic pain after laparoscopic bariatric surgery: a randomized, placebo-controlled, double-blind trial.
Obes Surg. 2023;33(4):1192-1201.
Man KM, Lee SO, Lu CH, Wong CS, Sun WZ.
Injection site reactions before and after intramuscular injection technique revision: a postmarketing analysis of NALDEBAIN® from 2017 to 2022.
Asian J Anesthesiol. 2023;61(1):14-20.