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The Effect of Neuraxial Analgesia on Maternal Breastfeeding

4 april 2022 uppdaterad av: Paloma Toledo, Northwestern University

A previous randomized trial showed a possible negative association with labor neuraxial analgesia with high compared to low doses of fentanyl, and breastfeeding at 6 weeks postpartum. The significance of this study would be to validate or refute these findings. In addition, we hope to better evaluate the impact of cumulative dose of fentanyl on breastfeeding success in the initial postpartum period as well as at 6 weeks and 6 months post delivery. In order to better assess the quality of breastfeeding, we will utilize a validated breastfeeding assessment tool, LATCH (Latch, Audible swallowing, Type of Nipple, Comfort, and Help). This validated tool can assess maternal and infant variables, define areas of needed intervention, and determine priorities in providing patient teaching. The LATCH assessment has been shown to be a predictor of breastfeeding duration. We also plan to vary the dosage of fentanyl analgesia to determine the relationship between doses below 150 micrograms and changes in breastfeeding assessments. If a clear association between decreased breastfeeding and total fentanyl is identified, then regimens to reduce cumulative doses of fentanyl can be developed to improve the likelihood of breastfeeding success in mothers that desire to breastfeed.

Prior observational studies have inferred epidurals negatively affect breastfeeding by decreasing maternal plasma oxytocin release which may adversely affect infant neurobehavioral development. In a study by Beilin et al., it was reported that mothers receiving a high cumulative dose (> 150 microgram) epidural fentanyl were more likely to have stopped nursing 6 weeks postpartum compared with groups receiving no fentanyl or those receiving < 150 microgram. The study however, was underpowered to detect differences in breastfeeding prior to hospital discharge. In addition, the breastfeeding assessment tool utilized resulted in binary assessments, and therefore, a global rating of the quality of breastfeeding was not available.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Participants in this study will be asked to complete a questionnaire called the Intrinsic Motivation Inventory (IMI).

Subjects will be randomized at the time they request neuraxial analgesia to one of three groups: Group 1: patient controlled epidural analgesia (PCEA) with bupivacaine 1mg/mL; Group 2: PCEA with fentanyl 1 mcg/mL plus bupivacaine 0.8 mg/mL; Group 3: PCEA with fentanyl 2 mcg/mL plus bupivacaine 0.625 mg/mL. Labor analgesia will be initiated in all groups using fentanyl 15 mcg plus bupivacaine 2.5 mg administered intrathecally. A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.

The patient as well as individuals who evaluate the study patient will be blinded to the group assignment. Samples of maternal venous blood ½ teaspoon (2 mls) and cord blood 2ml (1/2 teaspoon) will be collected after the delivery of the fetus. Blood concentrations of fentanyl and bupivacaine will be ascertained using high performance liquid chromatography (HPLC) analysis. Success of breastfeeding using the LATCH assessment tool will be measured by the lactation nurses within 24 hrs of delivery. At 6 weeks and at 3 months postpartum, follow-up phone calls by the anesthesia service will be made to assess for duration of breastfeeding. Also, the patient's obstetrician will be contacted to obtain the patient's Edinburgh Postnatal Depression Score to assess for postpartum depression, which may be a variable in decreasing breastfeeding success.

Studietyp

Interventionell

Inskrivning (Faktisk)

345

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

  • Förenta staterna
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60611
        • Northwestern University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Age 18 and above
  • English speaking
  • Term gestation (> 38 weeks)
  • Parous parturients presenting for attempted vaginal delivery with a cervical dilation less than 8 cm
  • They must request neuraxial labor analgesia
  • Have previously successfully breastfed their child postpartum for at least 6 weeks
  • Are expressing an interest in exclusively breastfeeding postpartum

Exclusion Criteria:

  • Under 18 years of age
  • Parturients who have received parental opioids during labor or have taken opioids prenatally
  • Patients whose neuraxial analgesia failed due to abnormal spinal anatomy including scoliosis or previous spinal instrumentation
  • Supplemental epidural opioids during labor
  • Had an expedited labor with the delivery of the fetus less than 90 minutes from the placement of the neuraxial anesthestic
  • Underwent cesarean delivery
  • Received general analgesia for an unanticipated postpartum procedure
  • Dropout criteria include patients who wished to be taken out of the study or were lost to follow-up

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Group 1
spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL
Läkemedel: Group 1
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Andra namn:
  • bupivacaine 1mg/ml
Experimentell: Group 2
spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg spinal followed by a PCEA infusion of fentanyl 1 micrograms/mL plus bupivacaine 0.8 mg/mL
Läkemedel: Group 2
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Andra namn:
  • fentanyl 1mcg/ml plus bupivacaine 0.8 mg/ml
Aktiv komparator: Group 3
spinal fentanyl 15 micrograms plus bupivacaine 2.5mg followed by a PCEA infusion of fentanyl 2 micrograms/mL plus bupivacaine 0.625 mg/mL
Läkemedel: Group 3
A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Andra namn:
  • fentanyl 2mcg/ml plus bupivacaine 0.625 mg/ml

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Breastfeeding at 6 Weeks Post Delivery
Tidsram: 6 weeks post delivery
Breastfeeding continuing at 6 weeks after delivery of the baby.
6 weeks post delivery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Breastfeeding at 3 Months After Delivery
Tidsram: 3 months after delivery
Breastfeeding at 3 months after delivery of baby
3 months after delivery

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cumulative Fentanyl Dose (Micrograms)
Tidsram: Time of epidural catheter removal
Total cumulative dose of fentanyl in micrograms
Time of epidural catheter removal
Plasma Fentanyl Concentration (ng/mL)
Tidsram: Time of epidural catheter removal
Blood plasma fentanyl concentraton (nanograms/milliliter).
Time of epidural catheter removal
Umbilical Vein Plasma Fentanyl Concentration (ng/mL)
Tidsram: Immediately after delivery
Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL)
Immediately after delivery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Northwestern University

Utredare

  • Huvudutredare: Paloma Toledo, M.D.,MPH, Northwestern University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 december 2016

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

22 februari 2010

Först inskickad som uppfyllde QC-kriterierna

23 februari 2010

Första postat (Uppskatta)

24 februari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STU00007275

Plan för individuella deltagardata (IPD)

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NEJ

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