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

Chang, Tsung‐Kun; Huang, Ching‐Wen; Su, Wei‐Chih; Tsai, Hsiang‐Lin; Ma, Cheng‐Jen; Yeh, Yung‐Sung; Chen, Yen-Cheng; Li, Ching‐Chun; Cheng, Kuang‐I; Su, Miao‐Pei; Wang, Jaw‐Yuan

doi:10.1007/s40122-020-00197-x

Cited by 11 publications

(15 citation statements)

References 17 publications

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“…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].…”

Section: Discussionsupporting

confidence: 86%

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

Zheng

Yeh

et al. 2022

Pain Ther

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Introduction:Patients undergoing upper extremity fracture surgery (UEFS) commonly suffer from unbearable acute pain. Opioids remain the mainstay of moderate to severe pain alleviation, although there is a growing concern regarding the increasing trend in misuse and abuse. This study aimed to observe the safety and efficacy of dinalbuphine sebacate (DS), a novel extended-release analgesic, along with multimodal analgesia (MMA) for post-UEFS pain control.Methods: We retrospectively reviewed the records of patients undergoing UEFS between August 2020 and January 2021. Eligible patients were included and divided into two groups, depending on the analgesic regimen. In the DS group, 150 mg DS was administered intramuscularly at least 12 h pre-operatively, while in the conventional analgesia (CA) group, 40 mg parecoxib was given within 3 h before surgery. Intraoperative fentanyl administration was guided by the Analgesia Nociception Index System in both groups. For breakthrough pain, fentanyl was used as rescue medicine in the

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Section: Discussionsupporting

confidence: 86%

“…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].…”

Section: Introductionmentioning

confidence: 99%

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

Zheng

Yeh

et al. 2022

Pain Ther

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“… 16 Furthermore, a randomized controlled study reported that a single dose of DNS was superior to intravenous PCA with fentanyl in patients who underwent laparotomy. 12 In the present study, the patients received laparotomic staging, debulking, or radical surgery for uterine, ovarian, or cervical cancers. For patients with suspected ovarian cancer, intraoperative frozen section diagnosis was performed during surgery.…”

Section: Discussionmentioning

confidence: 99%

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

Section: Introductionmentioning

confidence: 99%

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

Chang

Chen

et al. 2021

JPR

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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.

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“…Three previous randomized double-blind placebo-controlled trials have demonstrated that a single preoperative injection of 150 mg SDE provides significant clinical analgesic effects in the management of post-open surgery pain. [11–13] However, the results of this clinical trial did not find any significant additive analgesic effect of SDE compared with the intraoperative MMA only group (parecoxib and propacetamol with or without morphine) for acute pain up to 7 days after laparoscopic cholecystectomy. In comparison to the previous controlled studies, [11–13] there were 2 main differences in our study design.…”

Section: Discussionmentioning

confidence: 79%

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

Lee

Shiue

et al. 2023

Medicine

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Background: A long-acting κreceptor agonist parenteral analgesic may theoretically improve acute pain and reduce incidence of chronic postsurgical pain (CPSP) after laparoscopic cholecystectomy with minimal drug-related side effects of the traditional μreceptor opioids. Methods: Eighty adult patients undergoing elective laparoscopic cholecystectomy were randomly assigned to receive single intramuscular injection of an extended-release sebacoyl dinalbuphine ester (SDE, Naldebain 150 mg; n = 40) or placebo (n = 40) after anesthesia induction. Standard multimodal analgesia (MMA) was administered for postoperative pain control. The primary endpoint was pain intensity within 7 days after surgery. The secondary endpoints were incidence CPSP at 3 months and adverse reactions up to 7 days after surgery. Results: The highest visual analogue scale (VAS) and area under the curve of VAS 0 to 48 hours after operation were not different between the two groups and a similar proportion of patients requested rescue parenteral analgesics. Average pain intensities were also not different at 72 hours and 7 days after surgery. Incidence of CPSP was 22.5% and 13.1% in patients who received placebo and SDE treatment, respectively (P = .379). Significantly higher incidence of drug-related adverse events, including dizziness, nausea and injection site reactions, were recorded in the SDE group. Conclusion: A single dose of extended-release analgesic SDE given intraoperatively did not provide sufficient add-on effect for acute and chronic pain management after laparoscopic cholecystectomies in patients who received standard postoperative MMA. Intramuscular injection of 150 mg SDE in patients with average body mass causes adverse events that could have been overlooked. More clinical studies are warranted to determine the target populations who may benefit from SDE injections for improvement of acute and chronic postsurgical pain management.

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

Cited by 11 publications

References 17 publications

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

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

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

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

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