Anim-Somuah Millicent, Smyth Rebecca Md, Cyna Allan M, Cuthbert Anna
Tameside Hospital NHS Foundation Trust, Fountain Street, Ashton-under-Lyne, UK, OL6 9RW.
Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
Epidural analgesia is a central nerve block technique achieved by injection of a local anaesthetic close to the nerves that transmit pain, and is widely used as a form of pain relief in labour. However, there are concerns about unintended adverse effects on the mother and infant. This is an update of an existing Cochrane Review (Epidural versus non-epidural or no analgesia in labour), last published in 2011.
To assess the effectiveness and safety of all types of epidural analgesia, including combined-spinal-epidural (CSE) on the mother and the baby, when compared with non-epidural or no pain relief during labour.
We searched Cochrane Pregnancy and Childbirth's Trials Register (ClinicalTrials.gov), the WHO International Clinical Trials Registry Platform (ICTRP) (30 April 2017), and reference lists of retrieved studies.
Randomised controlled trials comparing all types of epidural with any form of pain relief not involving regional blockade, or no pain relief in labour. We have not included cluster-randomised or quasi-randomised trials in this update.
Two review authors independently assessed trials for inclusion and risks of bias, extracted data and checked them for accuracy. We assessed selected outcomes using the GRADE approach.
Fifty-two trials met the inclusion criteria and we have included data from 40 trials, involving over 11,000 women. Four trials included more than two arms. Thirty-four trials compared epidural with opioids, seven compared epidural with no analgesia, one trial compared epidural with acu-stimulation, one trial compared epidural with inhaled analgesia, and one trial compared epidural with continuous midwifery support and other analgesia. Risks of bias varied throughout the included studies; six out of 40 studies were at high or unclear risk of bias for every bias domain, while most studies were at high or unclear risk of detection bias. Quality of the evidence assessed using GRADE ranged from moderate to low quality.Pain intensity as measured using pain scores was lower in women with epidural analgesia when compared to women who received opioids (standardised mean difference -2.64, 95% confidence interval (CI) -4.56 to -0.73; 1133 women; studies = 5; I = 98%; low-quality evidence) and a higher proportion were satisfied with their pain relief, reporting it to be "excellent or very good" (average risk ratio (RR) 1.47, 95% CI 1.03 to 2.08; 1911 women; studies = 7; I = 97%; low-quality evidence). There was substantial statistical heterogeneity in both these outcomes. There was a substantial decrease in the need for additional pain relief in women receiving epidural analgesia compared with opioid analgesia (average RR 0.10, 95% CI 0.04 to 0.25; 5099 women; studies = 16; I = 73%; Tau = 1.89; Chi = 52.07 (P < 0.00001)). More women in the epidural group experienced assisted vaginal birth (RR 1.44, 95% CI 1.29 to 1.60; 9948 women; studies = 30; low-quality evidence). A post hoc subgroup analysis of trials conducted after 2005 showed that this effect is negated when trials before 2005 are excluded from this analysis (RR 1.19, 95% CI 0.97 to 1.46). There was no difference between caesarean section rates (RR 1.07, 95% CI 0.96 to 1.18; 10,350 women; studies = 33; moderate-quality evidence), and maternal long-term backache (RR 1.00, 95% CI 0.89 to 1.12; 814 women; studies = 2; moderate-quality evidence). There were also no clear differences between groups for the neonatal outcomes, admission to neonatal intensive care unit (RR 1.03, 95% CI 0.95 to 1.12; 4488 babies; studies = 8; moderate-quality evidence) and Apgar score less than seven at five minutes (RR 0.73, 95% CI 0.52 to 1.02; 8752 babies; studies = 22; low-quality evidence). We downgraded the evidence for study design limitations, inconsistency, imprecision in effect estimates, and possible publication bias.Side effects were reported in both epidural and opioid groups. Women with epidural experienced more hypotension, motor blockade, fever, and urinary retention. They also had longer first and second stages of labour, and were more likely to have oxytocin augmentation than the women in the opioid group. Women receiving epidurals had less risk of respiratory depression requiring oxygen, and were less likely to experience nausea and vomiting than women receiving opioids. Babies born to women in the epidural group were less likely to have received naloxone. There was no clear difference between groups for postnatal depression, headache, itching, shivering, or drowsiness. Maternal morbidity and long-term neonatal outcomes were not reported.Epidural analgesia resulted in less reported pain when compared with placebo or no treatment, and with acu-stimulation. Pain intensity was not reported in the trials that compared epidural with inhaled analgesia, or continuous support. Few trials reported on serious maternal side effects.
AUTHORS' CONCLUSIONS: Low-quality evidence shows that epidural analgesia may be more effective in reducing pain during labour and increasing maternal satisfaction with pain relief than non-epidural methods. Although overall there appears to be an increase in assisted vaginal birth when women have epidural analgesia, a post hoc subgroup analysis showed this effect is not seen in recent studies (after 2005), suggesting that modern approaches to epidural analgesia in labour do not affect this outcome. Epidural analgesia had no impact on the risk of caesarean section or long-term backache, and did not appear to have an immediate effect on neonatal status as determined by Apgar scores or in admissions to neonatal intensive care. Further research may be helpful to evaluate rare but potentially severe adverse effects of epidural analgesia and non-epidural analgesia on women in labour and long-term neonatal outcomes.
硬膜外镇痛是一种通过在传递疼痛的神经附近注射局部麻醉剂来实现的中枢神经阻滞技术,被广泛用作分娩时的一种镇痛方式。然而,人们担心其对母婴会产生意外的不良影响。这是对一篇现有Cochrane系统评价(分娩时硬膜外镇痛与非硬膜外镇痛或无镇痛)的更新,该评价上次发表于2011年。
评估与分娩时非硬膜外镇痛或无镇痛相比,各种类型的硬膜外镇痛(包括腰麻 - 硬膜外联合阻滞(CSE))对母婴的有效性和安全性。
我们检索了Cochrane妊娠与分娩试验注册库(ClinicalTrials.gov)、世界卫生组织国际临床试验注册平台(ICTRP)(截至2017年4月30日)以及检索到的研究的参考文献列表。
比较所有类型硬膜外镇痛与任何不涉及区域阻滞的镇痛形式或分娩时无镇痛的随机对照试验。在本次更新中,我们未纳入整群随机或半随机试验。
两名综述作者独立评估试验是否纳入及偏倚风险,提取数据并检查其准确性。我们使用GRADE方法评估选定的结局。
52项试验符合纳入标准,我们纳入了40项试验的数据,涉及超过11,000名女性。四项试验包含两个以上的组。34项试验比较了硬膜外镇痛与阿片类药物,七项试验比较了硬膜外镇痛与无镇痛,一项试验比较了硬膜外镇痛与针刺刺激,一项试验比较了硬膜外镇痛与吸入性镇痛,一项试验比较了硬膜外镇痛与持续助产支持及其他镇痛方法。纳入研究中的偏倚风险各不相同;40项研究中有六项在每个偏倚领域的偏倚风险为高或不明确,而大多数研究在检测偏倚方面的风险为高或不明确。使用GRADE评估的证据质量从中等质量到低质量不等。与接受阿片类药物的女性相比,接受硬膜外镇痛的女性使用疼痛评分测量的疼痛强度更低(标准化均数差 -2.64,95%置信区间(CI) -4.56至 -0.73;1133名女性;研究 = 5;I² = 98%;低质量证据),并且更高比例对其疼痛缓解感到满意,报告为“优秀或非常好”(平均风险比(RR)1.47,95% CI 1.03至2.08;1911名女性;研究 = 7;I² = 97%;低质量证据)。这两个结局均存在显著的统计学异质性。与阿片类镇痛相比,接受硬膜外镇痛的女性对额外镇痛的需求大幅减少(平均RR 0.10,95% CI 0.04至0.25;5,099名女性;研究 = 16;I² = 73%;Tau² = 1.89;Chi² = 52.07(P < 0.00001))。硬膜外组中有更多女性经历了阴道助产(RR 1.44,95% CI 1.29至1.60;9,948名女性;研究 = 30;低质量证据)。对2005年后进行的试验进行的事后亚组分析表明,当排除2005年前的试验后,这种效应消失(RR 1.19,95% CI 0.97至1.