The Effect of Neuraxial Analgesia on Maternal Breastfeeding
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Healthy Studies |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2017 |
| Start Date: | January 2010 |
| End Date: | December 2016 |
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.
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.
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.
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.
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
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