Ji Tianzhen, Xie Lei, Zhao Tingyu, Chen Zhengjie, Sun Xiaofen, Zhang Yan, Xu Cheng
Department of Anesthesiology, Anhui Province Maternal and Child Medical Center, Hefei Maternal and Child Health Hospital, Hefei, Anhui, People's Republic of China.
Department of Anesthesiology, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Drug Des Devel Ther. 2025 Sep 5;19:7763-7775. doi: 10.2147/DDDT.S532237. eCollection 2025.
Combined spinal-epidural (CSE) analgesia delivers rapid labor pain relief, yet high intrathecal opioid doses carry adverse effects, and ultra-low doses shorten block duration. Whether a low intrathecal dose of ropivacaine-sufentanil within CSE reduces clinician-delivered rescue boluses, compared with epidural analgesia (EA) or dural-puncture epidural (DPE), remains unclear.
Laboring women requesting neuraxial analgesia were randomized to three groups: EA, DPE, and CSE. In the CSE group, analgesia was initiated with 2 mL of solution (1 mL 0.1% ropivacaine plus 1 mL containing 1 μg sufentanil), while the EA and DPE groups received 15 mL of 0.09% ropivacaine with 0.4 μg/mL sufentanil. The primary outcome was the proportion of patients requiring supplemental provider-administered analgesia for breakthrough pain. Secondary outcomes included analgesia onset time, VAS scores at multiple time points, patient-controlled epidural analgesia button presses, and cumulative analgesic consumption.
A total of 131 women completed the study: 42 (EA), 44 (DPE), and 45 (CSE). After adjusting for age, gestational age, cervical dilation, ASA status, BMI, and baseline VAS, the CSE group showed a significantly lower need for supplemental analgesia compared to EA (22% vs 48%; adjusted odds ratio [aOR]: 0.29, 95% CI: 0.10-0.78; P=0.013). The DPE group (30%) also exhibited a lower incidence than EA, but the difference did not reach significance (aOR: 0.43, 95% CI: 0.16-1.09; P=0.09). Between CSE and DPE, no significant difference emerged (aOR: 0.66, 95% CI: 0.24-1.74; P=0.27). The primary hypothesis that CSE would outperform both EA and DPE was not fully supported. For secondary outcomes, the CSE group demonstrated faster onset and significantly lower VAS scores at prespecified intervals than DPE and EA (P<0.001).
Low-dose intrathecal ropivacaine-sufentanil CSE reduced supplemental analgesia needs versus EA but not DPE. Although CSE produced a faster onset and greater sensory block, its superiority over DPE was not established. Thus, CSE and DPE are clinically acceptable, with CSE potentially favored where minimal breakthrough pain is prioritized; further multicenter studies are warranted to confirm these findings.
ChiCTR2300076206. The trial is publicly available and is registered at www.chictr.org.cn on Sept 7, 2023.
腰麻-硬膜外联合（CSE）镇痛可迅速缓解分娩疼痛，但鞘内阿片类药物高剂量会带来不良反应，而超低剂量会缩短阻滞时间。与硬膜外镇痛（EA）或硬膜穿刺硬膜外镇痛（DPE）相比，CSE中低剂量鞘内罗哌卡因-舒芬太尼是否能减少临床医生给予的补救推注剂量尚不清楚。
要求进行神经轴镇痛的分娩妇女被随机分为三组：EA组、DPE组和CSE组。在CSE组中，用2毫升溶液（1毫升0.1%罗哌卡因加1毫升含1微克舒芬太尼）开始镇痛，而EA组和DPE组接受15毫升含0.4微克/毫升舒芬太尼的0.09%罗哌卡因。主要结局是因突破性疼痛需要补充由医护人员给予镇痛的患者比例。次要结局包括镇痛起效时间、多个时间点的视觉模拟评分（VAS）、患者自控硬膜外镇痛按钮按压次数以及累积镇痛药物消耗量。
共有131名妇女完成了研究：42名（EA组）、44名（DPE组）和45名（CSE组）。在调整年龄、孕周、宫颈扩张程度、美国麻醉医师协会（ASA）分级、体重指数（BMI）和基线VAS后，与EA组相比，CSE组补充镇痛的需求显著更低（22%对48%；调整后的优势比[aOR]：0.29，95%置信区间[CI]：0.10 - 0.78；P = 0.013）。DPE组（30%）的发生率也低于EA组，但差异无统计学意义（aOR：0.43，95% CI：0.16 - 1.09；P = 0.09）。CSE组和DPE组之间无显著差异（aOR：0.66，95% CI：0.24 - 1.74；P = 0.27）。CSE优于EA和DPE的主要假设未得到充分支持。对于次要结局，CSE组在预设时间段内的起效更快，VAS评分显著低于DPE组和EA组（P < 0.001）。
低剂量鞘内罗哌卡因-舒芬太尼CSE与EA相比减少了补充镇痛的需求，但与DPE相比未减少。尽管CSE起效更快且感觉阻滞更强，但其优于DPE的优势未得到证实。因此，CSE和DPE在临床上都是可接受的，在优先考虑最小化突破性疼痛的情况下CSE可能更受青睐；需要进一步的多中心研究来证实这些发现。
ChiCTR2300076206。该试验已公开，于2023年9月7日在www.chictr.org.cn注册。
