Intrathecal bupivacaine versus bupivacaine plus fentanyl for anaesthesia for Caesarean delivery: a randomised double-blind noninferiority trial

作者：Lihong Sun, Cui-Cui Jiao, Hui Wu, Ange Dai, Qing Chen, Lin Jin, Xiaoping Chen, Xiao-Ping Chen, Xiaowei Qian, Warwick D. Ngan Kee, Xinzhong Chen, Xinzhong Chen · 发表于：British Journal of Anaesthesia · 年份：2025 · DOI：10.1016/j.bja.2025.09.059 · 被引用次数：4 · 研究领域：Anesthesia and Pain Management、Veterinary Pharmacology and Anesthesia、Nausea and vomiting management

BACKGROUND: Fentanyl is commonly mixed with bupivacaine for spinal anaesthesia for Caesarean delivery. However, fentanyl has potential disadvantages. We hypothesised that simply increasing the bupivacaine dose would be at least as effective as adding fentanyl. METHODS: We performed a randomised, double-blinded trial in 626 women having elective Caesarean delivery under combined spinal-epidural anaesthesia to determine whether intrathecal hyperbaric bupivacaine 10.75 mg is noninferior to bupivacaine 9.0 mg plus fentanyl 15 μg for the primary outcome of effective anaesthesia, defined as T5 sensory block within 10 min and no intraoperative pain requiring treatment within the first 45 min. The chosen noninferiority margin was an absolute difference of 5%. Secondary outcomes included the incidences of intraoperative pain, nausea and vomiting, hypotension, and pruritus. RESULTS: Effective anaesthesia was achieved in 94.4% (95% confidence interval [CI], 91.1-96.7%) of patients with bupivacaine vs 92.5% (95% CI, 88.9-95.2%) with bupivacaine plus fentanyl. The absolute difference between groups was 1.9% (95% CI, -2.0% to 5.9%); because the lower confidence limit is greater than the noninferiority margin, noninferiority of bupivacaine was demonstrated (P=0.003). The incidence of pruritus was greater with bupivacaine plus fentanyl (7.2%) vs bupivacaine alone (0.7%) (P<0.001). There was no difference between groups for other secondary outcomes. CONCLUSIONS: Under the condition of this st...