Ropivacaine

The Basics

What is Ropivacaine?

Can be used to numb an area of the body to relieve pain before, during, or after surgery, a medical procedure, or childbirth.

Brand names for Ropivacaine

Naropin

How Ropivacaine is classified

Anesthetics – Local

Ropivacaine During Pregnancy

Ropivacaine pregnancy category

Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ropivacaine while pregnant

Reproduction toxicity studies have been performed in pregnant New Zealand white rabbits and Sprague-Dawley rats. During gestation days 6 to 18, rabbits received 1.3, 4.2, or 13 mg/kg/day subcutaneously. In rats, subcutaneous doses of 5.3, 11 and 26 mg/kg/day were administered during gestation days 6 to 15. No teratogenic effects were observed in rats and rabbits at the highest doses tested. The highest doses of 13 mg/kg/day (rabbits) and 26 mg/kg/day (rats) are approximately 1/3 of the maximum recommended human dose (epidural, 770 mg/24 hours) based on a mg/m2 basis. In 2 prenatal and postnatal studies, the female rats were dosed daily from day 15 of gestation to day 20 postpartum. The doses were 5.3, 11 and 26 mg/kg/day subcutaneously. There were no treatment-related effects on late fetal development, parturition, lactation, neonatal viability, or growth of the offspring. In another study with rats, the males were dosed daily for 9 weeks before mating and during mating. The females were dosed daily for 2 weeks before mating and then during the mating, pregnancy, and lactation, up to day 42 post coitus. At 23 mg/kg/day, an increased loss of pups was observed during the first 3 days postpartum. The effect was considered secondary to impaired maternal care due to maternal toxicity. There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Teratogenicity studies in rats and rabbits did not show evidence of any adverse effects on organogenesis or early fetal development in rats (26 mg/kg sc) or rabbits (13 mg/kg). The doses used were approximately equal to total daily dose based on body surface area. There were no treatment-related effects on late fetal development, parturition, lactation, neonatal viability, or growth of the offspring in 2 perinatal and postnatal studies in rats, at dose levels equivalent to the maximum recommended human dose based on body surface area. In another study at 23 mg/kg, an increased pup loss was seen during the first 3 days postpartum, which was considered secondary to impaired maternal care due to maternal toxicity.

Taking Ropivacaine While Breastfeeding

What are recommendations for lactation if you're taking Ropivacaine?

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.[1] Labor pain medication may delay the onset of lactation.

Maternal / infant drug levels

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.[1] Labor pain medication may delay the onset of lactation.

Possible effects of Ropivacaine on milk supply

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.[3]

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.[4]

A nonrandomized study at one Italian hospital compared primaparous 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.[5]

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.[6]

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%).[7]

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.[8]

Possible alternatives to Ropivacaine

Bupivacaine, Lidocaine.