毒理性
◉ 母乳喂养期间使用总结：罗哌卡因进入乳汁的情况较差，且不会被哺乳的婴儿口服吸收。婴儿似乎不会受到母乳中少量药物的影响。
在分娩期间与其他麻醉药和镇痛药联合使用的局部麻醉药，有人报道称会干扰哺乳。然而，由于研究了多种不同的药物组合、剂量和患者群体，以及使用的多种技术，这种评估存在争议和复杂性。在一小部分妇女中，对罗哌卡因和芬太尼在分娩期间的使用进行的研究发现，对哺乳的影响很小或没有不良影响。尽管罗哌卡因的研究不是特别充分，但看来在良好的哺乳支持下，硬脊膜外麻醉药无论是否与芬太尼或其衍生物联合使用，对哺乳成功的影响很小或没有。分娩疼痛药物可能会延迟哺乳的开始。
◉ 对哺乳婴儿的影响：有25名婴儿，其母亲在剖宫产时接受了罗哌卡因和芬太尼的组合用于患者控制硬脊膜外镇痛，这些婴儿的Apgar评分、神经适应能力评分均正常。没有任何一名婴儿出现不良反应。
◉ 对泌乳和母乳的影响：一项前瞻性队列研究比较了未接受镇痛（n = 63）的妇女与在分娩期间接受持续硬脊膜外镇痛（包括芬太尼和0.08%或0.2%罗哌卡因n = 13或布比卡因n = 39）的妇女。罗哌卡因的总剂量为50至124毫克，从开始输注到分娩的平均总时间为219分钟。研究发现，在分娩后8至12小时或产后4周，两组在哺乳效果或婴儿神经行为状态方面没有差异。
一项随机、前瞻性研究比较了接受硬脊膜外分娩镇痛（罗哌卡因n = 75）的母亲与未接受分娩镇痛（n = 49）的母亲。在治疗组中，首先注射3毫升0.125%罗哌卡因，随后一些母亲接受了额外的12毫升。在所有接受治疗的母亲中，随后以每小时5毫升的速度连续硬脊膜外输注。尽管接受罗哌卡因的组血清催乳素浓度略低，但在哺乳开始时间、广泛哺乳的母亲数量以及婴儿体重减少方面，两组之间没有差异。
在一项意大利医院的非随机研究中，比较了接受硬脊膜外镇痛（n = 64）的初产妇与未接受硬脊膜外镇痛（n = 64）的初产妇。要求硬脊膜外镇痛的母亲首先接受了100微克芬太尼稀释到10毫升生理盐水的初始剂量。在初始芬太尼之后，根据需要给予了15至20毫升0.1%罗哌卡因；然而，接受罗哌卡因的母亲人数并未报告。两组母亲之间的唯一差异是接受治疗的母亲分娩时间较长。两组婴儿在几次测量中的哺乳质量相等；然而，在第一次哺乳时，接受治疗的组中更多的婴儿哺乳时间少于30分钟。
一项全国性的调查，对从晚期妊娠到产后12个月的母亲及其婴儿进行了比较，研究了在分娩期间接受和不接受疼痛药物的母亲哺乳II期（lactogenesis II）的时间。药物类别包括脊髓或硬脊膜外单独用药、脊髓或硬脊膜外加用其他药物、以及其他疼痛药物单独使用。与未接受分娩疼痛药物的妇女相比，接受任何类别药物的妇女哺乳II期延迟（>72小时）的风险大约增加了一倍。
在一项非随机便利样本研究中，分析了在分娩期间接受（n = 209）和未接受（n = 157）硬脊膜外镇痛的妇女，以确定硬脊膜外麻醉是否影响哺乳的开始。尽管没有标准化，通常的程序是使用舒芬太尼10至15毫克与0.1%罗哌卡因或0.0625%左布比卡因硬脊膜外给药，每隔约2小时补充硬脊膜外注射0.1%罗哌卡因或0.0625%左布比卡因。两组在哺乳开始时间方面没有差异。尽管两组妇女在分娩前都表示希望哺乳，但在接受硬脊膜外麻醉的妇女中，产后20天纯哺乳的频率（43%）低于未接受的妇女（57%）。
在一项西班牙公立医院的回顾性研究中，比较了在分娩期间接受含有芬太尼和布比卡因或罗哌卡因硬脊膜外麻醉的母亲的婴儿。接受硬脊膜外麻醉的母亲的婴儿早期哺乳的频率较低。
在中国的一项研究中，比较了正常阴道分娩期间硬脊膜外输注罗哌卡因700微克/小时（n = 76）与舒芬太尼1.75微克/小时加罗哌卡因700微克/小时（n = 81）。与单独使用罗哌
◉ Summary of Use during Lactation:Ropivacaine passes into milk poorly and is not orally absorbed by breastfed infants. Infants appear not to be affected by the small amounts of drug in breastmilk.
Local anesthetics administered during labor and delivery with other anesthetics and analgesics have been reported by some to interfere with breastfeeding. However, this assessment is controversial and complex because of the many different combinations of drugs, dosages and patient populations studied as well as the variety of techniques used. Published data on the use of ropivacaine and fentanyl used during labor and delivery in a small number of women found little or no adverse effect on breastfeeding. Although not well studied specifically with ropivacaine, it appears that with good breastfeeding support, epidural local anesthetics with or without fentanyl or one of its derivatives has little or no adverse effect on breastfeeding success. Labor pain medication may delay the onset of lactation.
◉ Effects in Breastfed Infants:Twenty-five infants whose mothers received a combination of ropivacaine and fentanyl for patient-controlled epidural analgesia for pain associated with cesarean section had normal Apgar and Neurological and Adaptive Capacity scores. No adverse effects were noted in any of the infants.
◉ Effects on Lactation and Breastmilk:A prospective cohort study compared women who received no analgesia (n = 63) to women who received continuous epidural analgesia with fentanyl and either 0.08 or 0.2% ropivacaine (n = 13) or bupivacaine (n = 39) during labor and delivery. The total dosage of ropivacaine was 50 to 124 mg and the average total infusion time from start to delivery was 219 minutes. The study found no differences between the groups in breastfeeding effectiveness or infant neurobehavioral status at 8 to 12 hours postpartum or the number exclusively or partially breastfeeding at 4 weeks postpartum.
A randomized, prospective study compared mothers who received epidural labor analgesia with ropivacaine (n = 75) to mothers who did not receive labor analgesia (n = 49). In the treatment group, 3 mL of ropivacaine 0.125% was injected epidurally, followed in some mothers by an additional 12 mL. In all treated mothers, 5 mL per hour was then given as a continuous epidural infusion. Although serum prolactin concentrations were somewhat lower in the group who received ropivacaine, no difference was seen between the groups in time of lactation onset, number of women with extensive lactation, and the decrease in infant weight reduction.
A nonrandomized study at one Italian hospital compared primiparous mothers undergoing vaginal delivery who received epidural analgesia (n = 64) to those who did not (n = 64). Mothers who requested the epidural analgesia received an initial dose of 100 mcg of fentanyl diluted to 10 mL with saline. After the initial fentanyl, doses of 15 to 20 mL of 0.1% ropivacaine were administered, if needed; however, the number of women who received ropivacaine was not reported. The only difference between the groups of mothers was a longer duration of labor among the treated mothers. The quality of infant nursing was equal between the 2 groups of infants on several measures; however, more infants in the treated group breastfed for less than 30 minutes at the first feeding.
A national survey of women and their infants from late pregnancy through 12 months postpartum compared the time of lactogenesis II in mothers who did and did not receive pain medication during labor. Categories of medication were spinal or epidural only, spinal or epidural plus another medication, and other pain medication only. Women who received medications from any of the categories had about twice the risk of having delayed lactogenesis II (>72 hours) compared to women who received no labor pain medication.
A nonrandomized convenience sample of women who did (n = 209) or did not (n = 157) receive epidural analgesia during labor was analyzed to determine whether epidurals affected the onset of lactation. Although not standardized, the typical procedure used sufentanil 10 to 15 mg together with either ropivacaine 0.1% or levobupivacaine 0.0625% epidurally, supplemented by epidural boluses of ropivacaine 0.1% or levobupivacaine 0.0625% about every 2 hours. No difference was found in the time of lactation onset between the two groups. Although women in both groups stated they wished to breastfeed prior to delivery, exclusive breastfeeding at 20 days postpartum was less frequent in the women who received an epidural (43%) than in women who did not (57%).
A retrospective study in a Spanish public hospital compared the infants of mothers who received an epidural during labor that contained fentanyl and either bupivacaine or ropivacaine. Infants of mothers who received an epidural had a lower frequency of early breastfeeding.
A study in China compared an epidural infusion of ropivacaine 700 mcg/hour (n = 76) to sufentanil 1.75 mcg/hour plus ropivacaine 700 mcg/hour (n = 81) during normal vaginal delivery. The combined ropivacaine and sufentanil provided better pain control than ropivacaine alone. Onset of lactation was shorter and lactation adequacy (milk volume) was better in the combined group than in the ropivacaine-only group.
来源:Drugs and Lactation Database (LactMed)
