METHODS: This double-blinded randomized clinical trial compared the consequences of the (12.5mg,15mg,20mg) dosages of HB-bupivacaine in elective lower limb orthopedic surgery. Using block randomization, we allocated 60 participants to three (n = 20) study groups. Utilizing the same protocol of anesthesia induction, outcome variables assumed and measured as the incidence of the adverse effects (Hypotension, Anxiety, Bradycardia, Nausea and Vomiting(N/V), Hypoventilation, and Decreased o2 saturation), and the requirement for intervention to control the unwanted reaction. Addressing that, outcome variables were measured 10 times perioperatively. One-way ANOVA test, the chi2 test, or repeated measures ANOVA test with the Bonferroni adjustment were utilized as appropriate.
RESULTS: We found that the incidence of hypotension (P-value:0.02) and the N/V (P-value < 0.001) are associated with the HB-bupivacaine dosage. Contrary, our findings indicate that the incidence of apnea, bradycardia, and hypoventilation did not exhibit a significant dose-dependent pattern between the groups. Repeated measures analysis revealed significant intergroup differences for Herat rate, systolic, diastolic, and mean arterial pressure (group*time Pvalue < 0.001). The observed differences were more prominent 10-30 min after injection of HB-bupivacaine. The regression model claimed that gender (P-value:0.002) and drug dosage (P-value:0.03) significantly predict the incidence of adverse effects.
CONCLUSIONS: Our results, suggest that the administration of the 12.5mg HB-bupivacaine provides adequate anesthesia while minimizing the risk of adverse events for lower limb orthopedic surgeries lasting up to 180 min.
BACKGROUND: The study was registered at the Clinical Trial Registry Center (IRCT20160202026328N7), Registered on 2022.01.10.
方法:这项双盲随机临床试验比较了(12.5mg,15mg,20mg)剂量的HB-布比卡因在择期下肢骨科手术中的应用。使用块随机化,我们将60名参与者分配到3个研究组(n=20).利用相同的麻醉诱导方案,结果变量假定并测量为不良反应的发生率(低血压,焦虑,心动过缓,恶心和呕吐(N/V),通气不足,并降低O2饱和度),以及控制不必要反应的干预要求。解决这个问题,围手术期测量结果变量10次.单因素方差分析测试,chi2测试,适当时使用带有Bonferroni调整的重复测量ANOVA检验。
结果:我们发现低血压的发生率(P值:0.02)和N/V(P值<0.001)与HB-布比卡因的剂量有关。相反,我们的研究结果表明呼吸暂停的发生率,心动过缓,和低通气组之间没有显著的剂量依赖性模式.重复测量分析显示赫拉特比率的显著组间差异,收缩压,舒张压,和平均动脉压(组*时间P值<0.001)。观察到的差异在注射HB-布比卡因后10-30分钟更为突出。回归模型认为性别(P值:0.002)和药物剂量(P值:0.03)显著预测不良反应的发生率。
结论:我们的结果,提示12.5mgHB-布比卡因的给药可提供足够的麻醉,同时将下肢骨科手术持续180分钟的不良事件风险降至最低.
背景:该研究已在临床试验注册中心(IRCT20160202026328N7)注册,于2022.01.10注册。