The Effect of Neuraxial Analgesia on Maternal Breastfeeding

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.

Study Overview

• Status: Completed
• Conditions: Pain; Breastfeeding
• Intervention / Treatment: Drug: Group 1; Drug: Group 2; Drug: Group 3

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 345
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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.; Other Names: bupivacaine 1mg/ml
Experimental: 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	Drug: 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.; Other Names: fentanyl 1mcg/ml plus bupivacaine 0.8 mg/ml
Active Comparator: 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	Drug: 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.; Other Names: fentanyl 2mcg/ml plus bupivacaine 0.625 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding at 6 Weeks Post Delivery	Breastfeeding continuing at 6 weeks after delivery of the baby.	6 weeks post delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding at 3 Months After Delivery	Breastfeeding at 3 months after delivery of baby	3 months after delivery

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Paloma Toledo, M.D.,MPH, Northwestern University

Publications and helpful links

General Publications

• Baumgarder DJ, Muehl P, Fischer M, Pribbenow B. Effect of labor epidural anesthesia on breast-feeding of healthy full-term newborns delivered vaginally. J Am Board Fam Pract. 2003 Jan-Feb;16(1):7-13. doi: 10.3122/jabfm.16.1.7.
• Beilin Y, Bodian CA, Weiser J, Hossain S, Arnold I, Feierman DE, Martin G, Holzman I. Effect of labor epidural analgesia with and without fentanyl on infant breast-feeding: a prospective, randomized, double-blind study. Anesthesiology. 2005 Dec;103(6):1211-7. doi: 10.1097/00000542-200512000-00016.
• Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs. 1994 Jan;23(1):27-32. doi: 10.1111/j.1552-6909.1994.tb01847.x.
• Rahm VA, Hallgren A, Hogberg H, Hurtig I, Odlind V. Plasma oxytocin levels in women during labor with or without epidural analgesia: a prospective study. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1033-9. doi: 10.1034/j.1600-0412.2002.811107.x.
• Riordan J, Gross A, Angeron J, Krumwiede B, Melin J. The effect of labor pain relief medication on neonatal suckling and breastfeeding duration. J Hum Lact. 2000 Feb;16(1):7-12. doi: 10.1177/089033440001600103.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Infant; Breastfeeding; Epidural Labor Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: STU00007275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO