This case study, indicates that the
findings have a lack of correlation between the cumulative epidural Fentanyl
dose and the discontinuation of breastfeeding within 3 months postpartum women,
who successfully breastfed in prior pregnancies. Of the 345 women enrolled in
the case study, 93% completed breastfeeding at 3 months postpartum, of which
77% discontinued due to maternal reasonings. From this, we conclude that the
Epidural solution with Fentanyl concentration as high as 2µg/mL does not
interfere with subsequent breastfeeding.
The outcomes further indicated that
of the possible 956 women that were eligible from February 2010 to January
2015, only 345 women were enrolled into the case study, from which 26 females’
results were inconclusive due to no follow-up for the 3-month assessment. The results
include no difference in the breastfeeding rate at 6 weeks and 3-month
follow-up period as the frequency at 6 weeks was 97% with no Fentanyl, 98% with
Fentanyl, and 94% with 2µg/mL Fentanyl. There was also no change in the sensitivity
analysis due to discontinuation, mainly because the reasonings are related to maternal
versus infant. Prior to breast-feeding, during delivery, women with no Fentanyl
showed an elevated motor block at the time of delivery when compared to women
who received 2µg/mL. At delivery, there were also variations in the cumulative
Fentanyl/Bupivacaine doses and the maternal plasma concentrations. However,
results show no variation within groups for maternal or infant recorded assessments,
except the umbilical cord venous Fentanyl and Bupivacaine concentrations.
The primary outcomes included a
chi-squared analysis of the rate of breastfeeding throughout 6 weeks and
Pearson-Klopper method analysis of the breastfeeding rate change, which was
known to be the confidence interval that is determined via binomial
distribution of two possible outcomes that are performed multiple times. The
secondary outcomes included Kruskal-Wallis H test for continuous and interval
data of the Apgar scores and LATCH breastfeeding assessments. Dunn’s test with
Bonferroni correction was used for post hoc comparisons for rate of
mother discontinuing breastfeeding at 3 months and reasons for discontinuation.
The nominal data was further analyzed with chi-squared analysis to determine
possible rejection of null hypothesis (P value <0.05). The Mann Whitney U test was used to compare the cumulative Epidural Fentanyl dose concentrations, which were dependent on both the Epidural Fentanyl concentration and duration of labor analgesia, for women who discontinued breastfeeding prior to the 6 weeks, to determine possible correlation between the two independent factors. Lastly, a multivariable logistic regression model was used to estimate the risk factors that were identified on univariable analysis with discontinuation of breastfeeding at 6-week postpartum. The next set of data was recorded after delivery from both the mother and the infant. The data from the mother included: analgesia satisfactory (0-100), mode of delivery, duration of Epidural infusion, total Epidural infuse volume, and manual Bupivacaine bolus doses for breakthrough pain. The data from the infant included: birth weight, umbilical cord blood gas values, one-minute Apgar score, and NICU admission. After delivery, breastfeeding was assessed by one of three lactation consultants and at discharge, the mothers were inquired regarding mother-infant skin contact within the initial 24 hours. Six weeks and three months postpartum, the mothers were contacted for the last amount of data, which included the duration of breastfeeding by blinded research nurses. Had the mothers discontinued breastfeeding, they were asked open-ended questions regarding the reasoning behind the discontinuation. The research nurses further analyzed the data of the primary and secondary outcomes. The patient was asked to state a verbal pain score (0-100). Along with that, the upper sensory analgesia to ice and degree of motor blockade using a 4-point Bromage Scale. During this, the intensity of the motor block was analyzed by the patient's potential to move their lower extremities. The motor blockade was repeated twice, once at the 2-hour post injection and once at delivery. Samples of maternal venous blood (MV) and umbilical cord venous blood (UV) were collected into a 3mL spray coated Lithium Heparin and Polymer separator gel tubes at delivery. The samples were further centrifuged and stored at -20°C until analysis by HP (High Perform) liquid chromatographer of the plasma concentration and mass spectrometer of the concentrations of Fentanyl and Bupivacaine. The internal standards for the mass spectrometer were set by using Alfentanil for Fentanyl and Mepivacaine for Bupivacaine. For the Fentanyl plasma, a linear curve from 0.01ng/mL to 2.5ng/mL with a coefficient variance of less than or equal to 15% was set. For the Bupivacaine plasma, a linear curve from 1.0ng/mL to 100.0ng/mL with a coefficient variance of less than or equal to 15% was set. The analgesia solutions were made by a Pharmacist that was not related to the study, so there would be a decrease in error to the findings. The solutions consisted of (1) Bupivacaine 1mg/mL + Fentanyl 0µg/mL, (2) Bupivacaine 0.8mg/mL + Fentanyl 1µg/mL, and (3) Bupivacaine 0.625mg/mL + Fentanyl 2µg/mL. When the solutions were ready, they were given to the research nurse, who was the only personnel not to be blinded by the group distribution. The research nurse further set up the PCEA (Patient Controlled Epidural Analgesia) pump to a basal infusion rate of 8mL/hour along with lock-out intervals for 10 minutes and infusion limit of 32mL for 8mL patient administered Epidural boluses. If the bolus, was not sufficient to alleviate the breakthrough pain, an Anesthesia provider was informed to administer Bupivacaine 1.25mg/mL with no Fentanyl. Fifteen minutes after the intrathecal injection, the first data was recorded. The selected subjects needed to have the following pre-requisites in order to be accepted into the study: English-speaking, 38+ week gestation with previous breastfeeding experience for at least 6 weeks, willing to breastfeed for at least 3 months, and willing to receive neuraxial labor analgesia. Further, the selection process indicated that the subjects needed to have no parenteral opioid prior to neuraxial labor analgesia, no history of chronic opioid therapy, and no expectation of delivery within 90 minutes of request for analgesia. After all the requirements were met, the subjects were randomly placed in three groups. The group the patient was placed in determined the amount of analgesia they would receive. The article Epidural Labor Analgesia – Fentanyl Dose and Breastfeeding Success, concentrated on the effects Epidural with Fentanyl had on breastfeeding. Many studies similar to this have occurred previously, however due to the inconclusive and controversial results, this study was repeated with alterations. This current study focused primarily on early termination of breastfeeding within three-time periods, which are postpartum, 6 weeks postpartum, and 3 months postpartum. The formed hypothesis was that early termination at 6 weeks postpartum would occur due to the cumulative Epidural Fentanyl dose. Along with the termination, the researchers had kept order of one-minute Apgar scores, day one LATCH breastfeeding assessments, breastfeeding discontinuation at 3-month rate, and reasonings for breastfeeding discontinuation. Prior to beginning this study, subjects had to be selected.