Breastfeeding, Pain
Conditions
Keywords
Epidural Labor Analgesia, Pain, Infant, Breastfeeding
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.
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.
Interventions
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.
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding at 6 Weeks Post Delivery | 6 weeks post delivery | Breastfeeding continuing at 6 weeks after delivery of the baby. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding at 3 Months After Delivery | 3 months after delivery | Breastfeeding at 3 months after delivery of baby |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Fentanyl Dose (Micrograms) | Time of epidural catheter removal | Total cumulative dose of fentanyl in micrograms |
| Plasma Fentanyl Concentration (ng/mL) | Time of epidural catheter removal | Blood plasma fentanyl concentraton (nanograms/milliliter). |
| Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | Immediately after delivery | Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 111 |
| 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
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. | 109 |
| 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
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. | 112 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Delivered in under 90 minutes | 0 | 2 | 1 |
| Overall Study | Emergency Cesarean Delivery | 1 | 2 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 0 |
| Overall Study | Subject withdrew consent | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 111 Participants | 109 Participants | 112 Participants | 332 Participants |
| Age, Continuous | 33 Years of age | 34 Years of age | 34 Years of age | 34 Years of age |
| Body Mass Index (kg/m∧ 2) | 28 Kilograms/meters squared | 28 Kilograms/meters squared | 29 Kilograms/meters squared | 28 Kilograms/meters squared |
| Breastfeeding at lactation consultant assessment n (%) Consultant not available | 5 Participants | 4 Participants | 11 Participants | 20 Participants |
| Breastfeeding at lactation consultant assessment n (%) No | 8 Participants | 9 Participants | 3 Participants | 20 Participants |
| Breastfeeding at lactation consultant assessment n (%) Yes | 98 Participants | 96 Participants | 98 Participants | 292 Participants |
| Breastfeeding motivational measurement scale | 119 Score on a scale | 117 Score on a scale | 117 Score on a scale | 118 Score on a scale |
| Duration of breastfeeding with last infant 3-6 months | 20 Participants | 31 Participants | 30 Participants | 81 Participants |
| Duration of breastfeeding with last infant Greater than 6 months | 82 Participants | 72 Participants | 73 Participants | 227 Participants |
| Duration of breastfeeding with last infant Less than three months | 9 Participants | 6 Participants | 9 Participants | 24 Participants |
| Gestational Age (Days) | 277 Days | 276 Days | 276 Days | 276 Days |
| Infant birth weight | 3.54 Kilograms | 3.61 Kilograms | 3.57 Kilograms | 3.56 Kilograms |
| LATCH score (0-2 for each factor) Audible swallowing | 2 Score on scale | 2 Score on scale | 2 Score on scale | 2 Score on scale |
| LATCH score (0-2 for each factor) Comfort (breast/nipple) | 2 Score on scale | 2 Score on scale | 2 Score on scale | 2 Score on scale |
| LATCH score (0-2 for each factor) Hold (positioning) | 1 Score on scale | 1 Score on scale | 1 Score on scale | 1 Score on scale |
| LATCH score (0-2 for each factor) Latch | 2 Score on scale | 2 Score on scale | 2 Score on scale | 2 Score on scale |
| LATCH score (0-2 for each factor) Total Score maximum 0-10 | 8.5 Score on scale | 8 Score on scale | 9 Score on scale | 8.5 Score on scale |
| LATCH score (0-2 for each factor) Type of nipple | 2 Score on scale | 2 Score on scale | 2 Score on scale | 2 Score on scale |
| Live Births | 1 live births | 1 live births | 1 live births | 1 live births |
| Mode of Delivery Assisted Vaginal Delivery | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Mode of Delivery Cesarean Delivery | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Mode of Delivery Vaginal Delivery | 111 Participants | 107 Participants | 110 Participants | 328 Participants |
| Number of times pregnant | 3 Number of times pregnant | 3 Number of times pregnant | 2 Number of times pregnant | 3 Number of times pregnant |
| Reason for discontinuing breastfeeding with last child Child eating solid foods/teething | 21 Participants | 17 Participants | 19 Participants | 57 Participants |
| Reason for discontinuing breastfeeding with last child Difficulty with breastfeeding | 9 Participants | 10 Participants | 5 Participants | 24 Participants |
| Reason for discontinuing breastfeeding with last child Inadequate milk production | 11 Participants | 19 Participants | 14 Participants | 44 Participants |
| Reason for discontinuing breastfeeding with last child Lack of time | 3 Participants | 2 Participants | 9 Participants | 14 Participants |
| Reason for discontinuing breastfeeding with last child Perceived time to stop | 22 Participants | 22 Participants | 20 Participants | 64 Participants |
| Reason for discontinuing breastfeeding with last child Pregnancy | 10 Participants | 9 Participants | 9 Participants | 28 Participants |
| Reason for discontinuing breastfeeding with last child Return to work | 35 Participants | 30 Participants | 36 Participants | 101 Participants |
| Region of Enrollment United States | 111 participants | 109 participants | 112 participants | 332 participants |
| Sex: Female, Male Female | 111 Participants | 109 Participants | 112 Participants | 332 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Skin-to-skin contact in the first 24 hours 0-25% | 35 Participants | 33 Participants | 43 Participants | 111 Participants |
| Skin-to-skin contact in the first 24 hours 25-50% | 28 Participants | 41 Participants | 39 Participants | 108 Participants |
| Skin-to-skin contact in the first 24 hours 50-75% | 23 Participants | 27 Participants | 25 Participants | 75 Participants |
| Skin-to-skin contact in the first 24 hours 75-100% | 13 Participants | 5 Participants | 3 Participants | 21 Participants |
| Skin-to-skin contact in the first 24 hours Did not remember | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Skin-to-skin contact in the first 24 hours Missing Data | 10 Participants | 0 Participants | 0 Participants | 10 Participants |
| Skin-to-skin contact in the first 24 hours post delivery 0-25% | 72 Participants | 70 Participants | 71 Participants | 213 Participants |
| Skin-to-skin contact in the first 24 hours post delivery 25-50% | 19 Participants | 2 Participants | 17 Participants | 38 Participants |
| Skin-to-skin contact in the first 24 hours post delivery 50-75% | 9 Participants | 8 Participants | 11 Participants | 28 Participants |
| Skin-to-skin contact in the first 24 hours post delivery 75-100% | 5 Participants | 0 Participants | 2 Participants | 7 Participants |
| Support for breastfeeding Missing Data | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Support for breastfeeding Moderate | 9 Participants | 13 Participants | 18 Participants | 40 Participants |
| Support for breastfeeding Strong | 101 Participants | 94 Participants | 93 Participants | 288 Participants |
| Support for breastfeeding Weak | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Time from delivery to initial breastfeeding 0 to 1 hour | 90 Participants | 80 Participants | 79 Participants | 249 Participants |
| Time from delivery to initial breastfeeding 1 to 3 hours | 9 Participants | 19 Participants | 16 Participants | 44 Participants |
| Time from delivery to initial breastfeeding 4 to 10 hours | 4 Participants | 4 Participants | 5 Participants | 13 Participants |
| Time from delivery to initial breastfeeding Did not remember | 4 Participants | 2 Participants | 5 Participants | 11 Participants |
| Time from delivery to initial breastfeeding Greater than 10 hours | 4 Participants | 4 Participants | 7 Participants | 15 Participants |
| Took a breastfeeding class or received breastfeeding education Did not take class or no response | 49 Participants | 57 Participants | 50 Participants | 156 Participants |
| Took a breastfeeding class or received breastfeeding education Took breastfeeding class | 62 Participants | 52 Participants | 62 Participants | 176 Participants |
| Used an assistive device/nipple shield Did not use device or no response | 92 Participants | 87 Participants | 94 Participants | 273 Participants |
| Used an assistive device/nipple shield Used Device | 19 Participants | 22 Participants | 18 Participants | 59 Participants |
| Verbal rating score for analgesia satisfaction (0-100) | 91 score on a scale | 91 score on a scale | 86 score on a scale | 89 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 109 | 0 / 112 |
| other Total, other adverse events | 0 / 111 | 0 / 109 | 0 / 112 |
| serious Total, serious adverse events | 0 / 111 | 0 / 109 | 0 / 112 |
Outcome results
Breastfeeding at 6 Weeks Post Delivery
Breastfeeding continuing at 6 weeks after delivery of the baby.
Time frame: 6 weeks post delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Breastfeeding at 6 Weeks Post Delivery | Not breastfeeding | 3 Participants |
| Group 1 | Breastfeeding at 6 Weeks Post Delivery | Currently breast feeding | 100 Participants |
| Group 1 | Breastfeeding at 6 Weeks Post Delivery | Lost to follow up | 8 Participants |
| Group 2 | Breastfeeding at 6 Weeks Post Delivery | Not breastfeeding | 2 Participants |
| Group 2 | Breastfeeding at 6 Weeks Post Delivery | Currently breast feeding | 99 Participants |
| Group 2 | Breastfeeding at 6 Weeks Post Delivery | Lost to follow up | 8 Participants |
| Group 3 | Breastfeeding at 6 Weeks Post Delivery | Currently breast feeding | 102 Participants |
| Group 3 | Breastfeeding at 6 Weeks Post Delivery | Lost to follow up | 4 Participants |
| Group 3 | Breastfeeding at 6 Weeks Post Delivery | Not breastfeeding | 6 Participants |
Breastfeeding at 3 Months After Delivery
Breastfeeding at 3 months after delivery of baby
Time frame: 3 months after delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Breastfeeding at 3 Months After Delivery | Not breastfeeding | 6 Participants |
| Group 1 | Breastfeeding at 3 Months After Delivery | Breastfeeding | 94 Participants |
| Group 1 | Breastfeeding at 3 Months After Delivery | Lost to follow up | 11 Participants |
| Group 2 | Breastfeeding at 3 Months After Delivery | Not breastfeeding | 4 Participants |
| Group 2 | Breastfeeding at 3 Months After Delivery | Breastfeeding | 96 Participants |
| Group 2 | Breastfeeding at 3 Months After Delivery | Lost to follow up | 9 Participants |
| Group 3 | Breastfeeding at 3 Months After Delivery | Breastfeeding | 93 Participants |
| Group 3 | Breastfeeding at 3 Months After Delivery | Lost to follow up | 7 Participants |
| Group 3 | Breastfeeding at 3 Months After Delivery | Not breastfeeding | 12 Participants |
Cumulative Fentanyl Dose (Micrograms)
Total cumulative dose of fentanyl in micrograms
Time frame: Time of epidural catheter removal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Cumulative Fentanyl Dose (Micrograms) | 15 fentalyl dose micrograms |
| Group 2 | Cumulative Fentanyl Dose (Micrograms) | 78 fentalyl dose micrograms |
| Group 3 | Cumulative Fentanyl Dose (Micrograms) | 139 fentalyl dose micrograms |
| Total | Cumulative Fentanyl Dose (Micrograms) | 78 fentalyl dose micrograms |
Plasma Fentanyl Concentration (ng/mL)
Blood plasma fentanyl concentraton (nanograms/milliliter).
Time frame: Time of epidural catheter removal
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Plasma Fentanyl Concentration (ng/mL) | .01 ng/mL |
| Group 2 | Plasma Fentanyl Concentration (ng/mL) | .07 ng/mL |
| Group 3 | Plasma Fentanyl Concentration (ng/mL) | .13 ng/mL |
| Total | Plasma Fentanyl Concentration (ng/mL) | .07 ng/mL |
Umbilical Vein Plasma Fentanyl Concentration (ng/mL)
Umbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL)
Time frame: Immediately after delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | .005 ng/mL |
| Group 2 | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | .03 ng/mL |
| Group 3 | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | .06 ng/mL |
| Total | Umbilical Vein Plasma Fentanyl Concentration (ng/mL) | .03 ng/mL |