This case study, indicates that thefindings have a lack of correlation between the cumulative epidural Fentanyldose and the discontinuation of breastfeeding within 3 months postpartum women,who successfully breastfed in prior pregnancies. Of the 345 women enrolled inthe case study, 93% completed breastfeeding at 3 months postpartum, of which77% discontinued due to maternal reasonings. From this, we conclude that theEpidural solution with Fentanyl concentration as high as 2µg/mL does notinterfere with subsequent breastfeeding. The outcomes further indicated thatof the possible 956 women that were eligible from February 2010 to January2015, 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 resultsinclude no difference in the breastfeeding rate at 6 weeks and 3-monthfollow-up period as the frequency at 6 weeks was 97% with no Fentanyl, 98% with1µg/mLFentanyl, and 94% with 2µg/mL Fentanyl. There was also no change in the sensitivityanalysis due to discontinuation, mainly because the reasonings are related to maternalversus infant.
Prior to breast-feeding, during delivery, women with no Fentanylshowed an elevated motor block at the time of delivery when compared to womenwho received 2µg/mL. At delivery, there were also variations in the cumulativeFentanyl/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 achi-squared analysis of the rate of breastfeeding throughout 6 weeks andPearson-Klopper method analysis of the breastfeeding rate change, which wasknown to be the confidence interval that is determined via binomialdistribution of two possible outcomes that are performed multiple times. Thesecondary outcomes included Kruskal-Wallis H test for continuous and intervaldata of the Apgar scores and LATCH breastfeeding assessments. Dunn’s test withBonferroni correction was used for post hoc comparisons for rate ofmother discontinuing breastfeeding at 3 months and reasons for discontinuation.The nominal data was further analyzed with chi-squared analysis to determinepossible rejection of null hypothesis (P value <0.
05). The Mann Whitney Utest was used to compare the cumulative Epidural Fentanyl dose concentrations,which were dependent on both the Epidural Fentanyl concentration and durationof labor analgesia, for women who discontinued breastfeeding prior to the 6weeks, to determine possible correlation between the two independent factors.Lastly, a multivariable logistic regression model was used to estimate the riskfactors that were identified on univariable analysis with discontinuation ofbreastfeeding at 6-week postpartum. The next set of data was recordedafter delivery from both the mother and the infant. The data from the motherincluded: analgesia satisfactory (0-100), mode of delivery, duration ofEpidural infusion, total Epidural infuse volume, and manual Bupivacaine bolusdoses 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 lactationconsultants and at discharge, the mothers were inquired regarding mother-infantskin contact within the initial 24 hours. Six weeks and three monthspostpartum, the mothers were contacted for the last amount of data, whichincluded the duration of breastfeeding by blinded research nurses.
Had themothers discontinued breastfeeding, they were asked open-ended questionsregarding the reasoning behind the discontinuation. The research nurses furtheranalyzed the data of the primary and secondary outcomes. The patient was asked to state averbal pain score (0-100). Along with that, the upper sensory analgesia to iceand degree of motor blockade using a 4-point Bromage Scale.
During this, theintensity of the motor block was analyzed by the patient’s potential to movetheir lower extremities. The motor blockade was repeated twice, once at the2-hour post injection and once at delivery. Samples of maternal venous blood(MV) and umbilical cord venous blood (UV) were collected into a 3mL spraycoated Lithium Heparin and Polymer separator gel tubes at delivery.
The sampleswere further centrifuged and stored at -20°C until analysis by HP (HighPerform) liquid chromatographer of the plasma concentration and massspectrometer of the concentrations of Fentanyl and Bupivacaine. The internalstandards for the mass spectrometer were set by using Alfentanil for Fentanyland Mepivacaine for Bupivacaine. For the Fentanyl plasma, a linear curve from0.01ng/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/mLwith a coefficient variance of less than or equal to 15% was set.The analgesia solutions were madeby a Pharmacist that was not related to the study, so there would be a decreasein 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 researchnurse, who was the only personnel not to be blinded by the group distribution.The research nurse further set up the PCEA (Patient Controlled EpiduralAnalgesia) pump to a basal infusion rate of 8mL/hour along with lock-outintervals for 10 minutes and infusion limit of 32mL for 8mL patientadministered Epidural boluses. If the bolus, was not sufficient to alleviatethe breakthrough pain, an Anesthesia provider was informed to administerBupivacaine 1.25mg/mL with no Fentanyl. Fifteen minutes after the intrathecalinjection, the first data was recorded. The selected subjects needed tohave the following pre-requisites in order to be accepted into the study:English-speaking, 38+ week gestation with previous breastfeeding experience forat least 6 weeks, willing to breastfeed for at least 3 months, and willing toreceive neuraxial labor analgesia. Further, the selection process indicatedthat the subjects needed to have no parenteral opioid prior to neuraxial laboranalgesia, no history of chronic opioid therapy, and no expectation of deliverywithin 90 minutes of request for analgesia.
After all the requirements weremet, the subjects were randomly placed in three groups. The group the patientwas placed in determined the amount of analgesia they would receive.The article Epidural LaborAnalgesia – Fentanyl Dose and Breastfeeding Success, concentrated on theeffects Epidural with Fentanyl had on breastfeeding. Many studies similar tothis have occurred previously, however due to the inconclusive and controversialresults, this study was repeated with alterations. This current study focusedprimarily on early termination of breastfeeding within three-time periods,which are postpartum, 6 weeks postpartum, and 3 months postpartum.
The formedhypothesis was that early termination at 6 weeks postpartum would occur due tothe cumulative Epidural Fentanyl dose. Along with the termination, theresearchers had kept order of one-minute Apgar scores, day one LATCHbreastfeeding assessments, breastfeeding discontinuation at 3-month rate, andreasonings for breastfeeding discontinuation. Prior to beginning this study,subjects had to be selected.