Center for Women's Reproductive Health, the Department of Obstetrics and Gynecology, the Department of Biostatistics, and the Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama; the Department of Women's Health, University of Texas at Austin, Dell Medical School, Austin, Texas; and the Department of Neuro-ophthalmology, University of Utah, Salt Lake City, Utah.
Obstet Gynecol. 2023 Nov 1;142(5):1179-1188. doi: 10.1097/AOG.0000000000005386. Epub 2023 Sep 28.
To evaluate the efficacy of occipital nerve block compared with standard care , defined as acetaminophen with caffeine, for treatment of acute headache in pregnancy.
We conducted a single-center, unblinded, parallel, randomized controlled trial of pregnant patients with headache and pain score higher than 3 on the visual rating scale. Patients with secondary headache, preeclampsia, or allergy or contraindication to study medications were excluded. Participants were randomized to occipital nerve block or standard care (oral 650 mg acetaminophen and 200 mg caffeine). Crossover treatment was given at 2 hours and second-line treatment at 4 hours to those with worsening visual rating scale score or visual rating scale score higher than 3. The primary outcome was headache improvement to a visual rating scale score of 3 or lower within 2 hours of initial therapy. Secondary outcomes included serial visual rating scale scores, receipt of crossover or second-line therapy, patient satisfaction, and perinatal outcomes. Outcomes were assessed in an intention-to-treat analysis. We estimated that a sample of 62 would provide 80% power to detect a difference from 85% to 50% between groups.
From February 2020 to May 2022, 62 participants were randomized to occipital nerve block (n=31) or standard care (n=31). Groups were similar except payer status. The primary outcome, headache improvement to visual rating scale score of 3 or lower, was not significantly different between groups (64.5% vs 51.6%, P =.30). The occipital nerve block group experienced lower median [interquartile range] visual rating scale scores at 1 hour (2 [0-5] vs 6 [2-7], P =.014), and more patients in the occipital nerve block group had visual rating scale scores of 3 or lower at 1 hour. Among patients receiving crossover treatment at 2 hours, the standard care group had a significantly lower visual rating scale score 1 hour after crossover to occipital nerve block than the occipital nerve block group receiving crossover to standard care ( P =.028). There were no significant differences in second-line treatment, refractory headache, satisfaction, or complications. Patients receiving occipital nerve block delivered earlier (36.6 weeks vs 37.8 weeks), but preterm birth did not differ between groups.
Occipital nerve block is an effective and quick-acting treatment option for acute headache in pregnancy.
ClinicalTrials.gov , NCT03951649.
评估枕神经阻滞与标准治疗（即对乙酰氨基酚加咖啡因）治疗妊娠急性头痛的疗效。
我们进行了一项单中心、非盲、平行、随机对照试验，纳入头痛且视觉评分量表（VRS）评分高于 3 的孕妇。排除继发性头痛、子痫前期、对研究药物过敏或禁忌的患者。参与者被随机分配至枕神经阻滞或标准治疗（口服 650mg 对乙酰氨基酚和 200mg 咖啡因）。VRS 评分恶化或评分高于 3 的患者在 2 小时时给予交叉治疗，在 4 小时时给予二线治疗。主要结局为初始治疗后 2 小时内头痛改善至 VRS 评分 3 分或以下。次要结局包括连续 VRS 评分、接受交叉或二线治疗、患者满意度和围产期结局。采用意向治疗分析评估结局。我们估计，纳入 62 例患者将有 80%的效能检测出组间从 85%到 50%的差异。
从 2020 年 2 月至 2022 年 5 月，共有 62 名参与者被随机分配至枕神经阻滞组（n=31）或标准治疗组（n=31）。除支付方类型外，两组患者相似。主要结局，即 VRS 评分降至 3 分或以下的头痛缓解率，两组间无显著差异（64.5%比 51.6%，P=.30）。枕神经阻滞组在 1 小时时的中位（四分位距）VRS 评分较低（2[0-5]比 6[2-7]，P=.014），且更多的枕神经阻滞组患者在 1 小时时 VRS 评分降至 3 分或以下。在接受 2 小时交叉治疗的患者中，与接受枕神经阻滞交叉治疗的患者相比，接受标准治疗交叉治疗的患者在接受枕神经阻滞交叉治疗后 1 小时的 VRS 评分显著更低（P=.028）。二线治疗、难治性头痛、满意度或并发症方面无显著差异。接受枕神经阻滞治疗的患者分娩更早（36.6 周比 37.8 周），但两组间早产率无差异。
枕神经阻滞是妊娠急性头痛的一种有效且起效迅速的治疗选择。
ClinicalTrials.gov，NCT03951649。
