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

Abstract

Objective We aimed to investigate the effects of dinalbuphine sebacate (DNS), fentanyl-based patient-controlled analgesia (PCA), and conventional analgesia (CA) for pain management after laparotomy for gynecologic cancers. Methods A total of 137 eligible patients who underwent laparotomy through a midline incision wound for gynecologic cancer between July 2019 and June 2020 were retrospectively evaluated. The patients were divided into three groups as follows: the intramuscular DNS, intravenous PCA, and CA groups. Postoperative pain (POP) intensity as measured with a numerical rating scale (NRS), total consumption of analgesics, and incidence of treatment-emergent adverse events were compared between the three groups. Results The DNS group showed significant reduction in NRS pain intensity than the PCA and CA groups on day 1 (4.8 vs 6.2, p < 0.01 and 6.2, p < 0.05, respectively), day 2 (3.0 vs 4.7, p < 0.01 and 4.8, p < 0.001, respectively), day 3 (2.0 vs 3.9, p < 0.001 and 3.5, p < 0.001, respectively), day 4 (1.1 vs 3.1, p < 0.001 and 2.9, p < 0.001, respectively), and day 5 (0.7 vs 2.3, p < 0.001 and 2.4, p < 0.001, respectively). The total consumption of morphine equivalents per day was similar between the DNS and PCA groups (142.8 ± 7.3 mg vs 137.7 ± 70.0 mg, p = 0.8032) and lowest in the CA group (11.7 ± 30.7 mg, p < 0.0001). The overall safety profile was comparable between the DNS, PCA, and CA groups. The patients in the DNS group complained less of dizziness postoperatively than those in the PCA group (27% vs 47%) and had less nausea than those in the CA group (13% vs 33%). Conclusion A single DNS injection was more effective for relieving POP than PCA and CA in the patients who had a longitudinal incision for gynecologic cancer surgery. DNS was well tolerated and had less adverse effects than PCA and CA.

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

“…Because ANI scores reflect changes in the nociceptive level with more sensitivity than traditional parameters such as heart rate and blood pressure, we used the ANI to determine the potential impact of DS on perioperative anaesthesia usage [30,31]. Even though DS was administered before surgery, we found no difference in fentanyl usage during surgery between the two groups, which is consistent with previous reports [13][14][15].…”

“…Further, the long-acting opioid nalbuphine, DS, is less dependent and The use of single-dose extended release of DS resulted in a relatively low maximum plasma concentration of nalbuphine [29], and the routine administration of antiemetics (dexamethasone and meclizine hydrochloride) led to a lower trend in dizziness, nausea and vomiting observed in our study. In a previous report of intramuscular DS, injection-site reactions such pain, erythema and swelling were commonly reported adverse effects (10-27.5%) [12,14,15]. In our DS group, only one patient (2%) experienced swelling with pain at the injection site.…”

“…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].…”

Efficacy and safety of an extended-release sebacoyl dinalbuphine ester for laparoscopic cholecystectomy: A randomized controlled trial

“…The drug-related adverse reactions of SDE were previously reported in the several prospective [11,12,20] and retrospective [24] clinical studies. In general, the adverse drug reactions include systemic responses reacting to the active compound nalbuphine (such as sedation, dizziness, nausea and vomiting) and focal reactions following intramuscular injection (such as soreness and tissue reactions at the injection site).…”

Breast Milk Excretion of Dinalbuphine Sebacate Injection Administered After Cesarean Section

“…6 In addition, the feasibility of dinalbuphine sebacate injection integrated with postoperative multimodal analgesia was also fully demonstrated in several abdominal and orthopedic surgeries. [7][8][9] However, the amount of nalbuphine or dinalbuphine sebacate excreted in breast milk and its potential impact on breastfed infants are not well understood. Current risk and benefit evaluation is based on limited data for nursing mothers receiving nalbuphine injections.…”