The Effect of Neuraxial Analgesia on Maternal Breastfeeding

NCT01074190 | Completed Results

• 1 other identifier: STU00007275
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Breastfeeding

Keywords

Epidural Labor Analgesia; Pain; Infant; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Breastfeeding at 6 Weeks Post Delivery

  Breastfeeding continuing at 6 weeks after delivery of the baby.

  6 weeks post delivery

Secondary Outcomes (1)

• Breastfeeding at 3 Months After Delivery

  3 months after delivery

Other Outcomes (3)

• Cumulative Fentanyl Dose (Micrograms)

  Time of epidural catheter removal

• Plasma Fentanyl Concentration (ng/mL)

  Time of epidural catheter removal

• Umbilical Vein Plasma Fentanyl Concentration (ng/mL)

  Immediately after delivery

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

ACTIVE COMPARATOR

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

Interventions

Group 1 DRUG

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.

Also known as: bupivacaine 1mg/ml

Group 1

Group 2 DRUG

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.

Also known as: fentanyl 1mcg/ml plus bupivacaine 0.8 mg/ml

Group 2

Group 3 DRUG

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.

Also known as: fentanyl 2mcg/ml plus bupivacaine 0.625 mg/ml

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 12583645 BACKGROUND

• 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.

  PMID: 11138228 BACKGROUND

• 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.

  PMID: 12421171 BACKGROUND

• 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.

  PMID: 16306734 BACKGROUND

• 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.

  PMID: 8176525 BACKGROUND

MeSH Terms

Conditions

Pain; Breast Feeding

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was limited because few of the participants required more than 150 micrograms of fentanyl for labor analgesia. This was the cut off for reduction of breastfeeding stated by earlier studies.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwerstern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Paloma Toledo, M.D.,MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)