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The Effect of Neuraxial Analgesia on Maternal Breastfeeding

4. april 2022 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

345

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: 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.
Andre navn:
  • bupivacaine 1mg/ml
Eksperimentell: 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
Legemiddel: 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.
Andre navn:
  • 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
Legemiddel: 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.
Andre navn:
  • fentanyl 2mcg/ml plus bupivacaine 0.625 mg/ml

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Breastfeeding at 6 Weeks Post Delivery
Tidsramme: 6 weeks post delivery
Breastfeeding continuing at 6 weeks after delivery of the baby.
6 weeks post delivery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Breastfeeding at 3 Months After Delivery
Tidsramme: 3 months after delivery
Breastfeeding at 3 months after delivery of baby
3 months after delivery

Andre resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northwestern University

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2010

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

22. februar 2010

Først innsendt som oppfylte QC-kriteriene

23. februar 2010

Først lagt ut (Anslag)

24. februar 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STU00007275

Plan for individuelle deltakerdata (IPD)

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NEI

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