Mohadeseh Masoumi, Mohammad Soleimani, Tara Shekari, Maryam Alaei, Mehrdad Sheikhvatan, Mojtaba Mojtahedzadeh, Kamal Basiri, Farhad Najmeddin, Seyyed Hossein Shafiei
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However, a gold-standard treatment has not been established.</p><p><strong>Objectives: </strong>This study aims to compare the efficacy of duloxetine and pregabalin within a multimodal analgesic regimen for managing postoperative pain and their opioid-sparing effects following knee fracture surgery.</p><p><strong>Methods: </strong>In this double-blind randomized clinical trial (RCT), 54 patients undergoing knee fracture surgery were randomized to receive either 75 mg oral pregabalin or 30 mg duloxetine twice daily, starting at least 24 hours prior to surgery and continuing up to 48 hours postoperatively. Pain severity was assessed at admission and at 6, 12, 24, and 48 hours post-operation. Patients reporting a pain score greater than six on a Numeric Rating Scale (NRS) received intramuscular morphine. Additionally, total opioid dose, associated complications, and drug adverse effects were monitored within the first 48 hours post-surgery.</p><p><strong>Results: </strong>Although there was no statistically significant difference between the duloxetine and pregabalin groups at each time point, the reduction in pain at the 48-hour mark was more pronounced in the duloxetine group compared to the pregabalin group. The duloxetine group required higher doses of morphine on the first day compared to the pregabalin group (3.96 ± 3.20 mg vs. 2.14 ± 2.72 mg, P = 0.022). However, on the second day, opioid rescue was required in three patients in the pregabalin group, whereas no patients in the duloxetine group required rescue. No clinically significant adverse effects were observed in either group.</p><p><strong>Conclusions: </strong>Duloxetine 60 mg per day is an equally effective perioperative alternative to pregabalin 150 mg per day, resulting in a slight increase in rescue opioid administration with equivalent analgesic efficacy during the first 24 hours postoperatively. 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There is increasing evidence supporting the benefits of multimodal analgesia, including the use of gabapentinoids and serotonin norepinephrine reuptake inhibitors (SNRIs), to minimize opioid consumption while effectively managing pain. However, a gold-standard treatment has not been established.</p><p><strong>Objectives: </strong>This study aims to compare the efficacy of duloxetine and pregabalin within a multimodal analgesic regimen for managing postoperative pain and their opioid-sparing effects following knee fracture surgery.</p><p><strong>Methods: </strong>In this double-blind randomized clinical trial (RCT), 54 patients undergoing knee fracture surgery were randomized to receive either 75 mg oral pregabalin or 30 mg duloxetine twice daily, starting at least 24 hours prior to surgery and continuing up to 48 hours postoperatively. Pain severity was assessed at admission and at 6, 12, 24, and 48 hours post-operation. Patients reporting a pain score greater than six on a Numeric Rating Scale (NRS) received intramuscular morphine. Additionally, total opioid dose, associated complications, and drug adverse effects were monitored within the first 48 hours post-surgery.</p><p><strong>Results: </strong>Although there was no statistically significant difference between the duloxetine and pregabalin groups at each time point, the reduction in pain at the 48-hour mark was more pronounced in the duloxetine group compared to the pregabalin group. The duloxetine group required higher doses of morphine on the first day compared to the pregabalin group (3.96 ± 3.20 mg vs. 2.14 ± 2.72 mg, P = 0.022). However, on the second day, opioid rescue was required in three patients in the pregabalin group, whereas no patients in the duloxetine group required rescue. 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引用次数: 0
摘要
背景:有效的术后疼痛管理,特别是在骨科手术中,提出了重大的挑战。越来越多的证据支持多模式镇痛的益处,包括使用加巴喷丁类药物和血清素去甲肾上腺素再摄取抑制剂(SNRIs),以减少阿片类药物的消耗,同时有效地控制疼痛。然而,黄金标准的治疗方法尚未确立。目的:本研究旨在比较度洛西汀和普瑞巴林在多模式镇痛方案中对膝关节骨折术后疼痛的治疗效果和它们的阿片类药物节约效果。方法:在这项双盲随机临床试验(RCT)中,54例接受膝关节骨折手术的患者随机接受75 mg口服普瑞巴林或30 mg度洛西汀,每日两次,至少在手术前24小时开始,并持续至术后48小时。在入院时以及术后6、12、24和48小时评估疼痛严重程度。在数字评定量表(NRS)中报告疼痛评分大于6分的患者接受肌肉注射吗啡。此外,术后48小时内监测阿片类药物总剂量、相关并发症和药物不良反应。结果:虽然在每个时间点度洛西汀组和普瑞巴林组之间没有统计学差异,但在48小时时,度洛西汀组疼痛的减轻比普瑞巴林组更明显。度洛西汀组第一天吗啡剂量高于普瑞巴林组(3.96±3.20 mg vs. 2.14±2.72 mg, P = 0.022)。然而,在第二天,普瑞巴林组中有3例患者需要阿片类药物救援,而度洛西汀组中没有患者需要救援。两组均未观察到明显的临床不良反应。结论:度洛西汀60mg /天与普瑞巴林150mg /天是一种同样有效的围手术期替代方案,导致术后24小时内阿片类药物的使用略有增加,且镇痛效果相当。它显示了明显的镇痛效果,术后24至48小时内阿片类药物的需求没有增加。
Perioperative Use of Pregabalin vs. Duloxetine for Pain Management of Knee Fracture Surgery: A Double-Blind Randomized Clinical Trial.
Background: Effective postoperative pain management, particularly in orthopedic procedures, presents significant challenges. There is increasing evidence supporting the benefits of multimodal analgesia, including the use of gabapentinoids and serotonin norepinephrine reuptake inhibitors (SNRIs), to minimize opioid consumption while effectively managing pain. However, a gold-standard treatment has not been established.
Objectives: This study aims to compare the efficacy of duloxetine and pregabalin within a multimodal analgesic regimen for managing postoperative pain and their opioid-sparing effects following knee fracture surgery.
Methods: In this double-blind randomized clinical trial (RCT), 54 patients undergoing knee fracture surgery were randomized to receive either 75 mg oral pregabalin or 30 mg duloxetine twice daily, starting at least 24 hours prior to surgery and continuing up to 48 hours postoperatively. Pain severity was assessed at admission and at 6, 12, 24, and 48 hours post-operation. Patients reporting a pain score greater than six on a Numeric Rating Scale (NRS) received intramuscular morphine. Additionally, total opioid dose, associated complications, and drug adverse effects were monitored within the first 48 hours post-surgery.
Results: Although there was no statistically significant difference between the duloxetine and pregabalin groups at each time point, the reduction in pain at the 48-hour mark was more pronounced in the duloxetine group compared to the pregabalin group. The duloxetine group required higher doses of morphine on the first day compared to the pregabalin group (3.96 ± 3.20 mg vs. 2.14 ± 2.72 mg, P = 0.022). However, on the second day, opioid rescue was required in three patients in the pregabalin group, whereas no patients in the duloxetine group required rescue. No clinically significant adverse effects were observed in either group.
Conclusions: Duloxetine 60 mg per day is an equally effective perioperative alternative to pregabalin 150 mg per day, resulting in a slight increase in rescue opioid administration with equivalent analgesic efficacy during the first 24 hours postoperatively. It demonstrates notable analgesic outcomes with no increased need for opioids between 24 to 48 hours post-surgery.
期刊介绍:
The Iranian Journal of Pharmaceutical Research (IJPR) is a peer-reviewed multi-disciplinary pharmaceutical publication, scheduled to appear quarterly and serve as a means for scientific information exchange in the international pharmaceutical forum. Specific scientific topics of interest to the journal include, but are not limited to: pharmaceutics, industrial pharmacy, pharmacognosy, toxicology, medicinal chemistry, novel analytical methods for drug characterization, computational and modeling approaches to drug design, bio-medical experience, clinical investigation, rational drug prescribing, pharmacoeconomics, biotechnology, nanotechnology, biopharmaceutics and physical pharmacy.