Trial Outcomes & Findings for The Effect of Neuraxial Analgesia on Maternal Breastfeeding (NCT NCT01074190)
NCT ID: NCT01074190
Last Updated: 2022-04-05
Results Overview
Breastfeeding continuing at 6 weeks after delivery of the baby.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
345 participants
Primary outcome timeframe
6 weeks post delivery
Results posted on
2022-04-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
115
|
|
Overall Study
COMPLETED
|
111
|
109
|
112
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Emergency Cesarean Delivery
|
1
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
|
Overall Study
Delivered in under 90 minutes
|
0
|
2
|
1
|
|
Overall Study
Subject withdrew consent
|
1
|
1
|
1
|
Baseline Characteristics
The Effect of Neuraxial Analgesia on Maternal Breastfeeding
Baseline characteristics by cohort
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
332 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
33 Years of age
n=93 Participants
|
34 Years of age
n=4 Participants
|
34 Years of age
n=27 Participants
|
34 Years of age
n=483 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=93 Participants
|
109 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
332 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=93 Participants
|
109 participants
n=4 Participants
|
112 participants
n=27 Participants
|
332 participants
n=483 Participants
|
|
Body Mass Index (kg/m∧ 2)
|
28 Kilograms/meters squared
n=93 Participants
|
28 Kilograms/meters squared
n=4 Participants
|
29 Kilograms/meters squared
n=27 Participants
|
28 Kilograms/meters squared
n=483 Participants
|
|
Number of times pregnant
|
3 Number of times pregnant
n=93 Participants
|
3 Number of times pregnant
n=4 Participants
|
2 Number of times pregnant
n=27 Participants
|
3 Number of times pregnant
n=483 Participants
|
|
Live Births
|
1 live births
n=93 Participants
|
1 live births
n=4 Participants
|
1 live births
n=27 Participants
|
1 live births
n=483 Participants
|
|
Gestational Age (Days)
|
277 Days
n=93 Participants
|
276 Days
n=4 Participants
|
276 Days
n=27 Participants
|
276 Days
n=483 Participants
|
|
Duration of breastfeeding with last infant
Less than three months
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Duration of breastfeeding with last infant
3-6 months
|
20 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Duration of breastfeeding with last infant
Greater than 6 months
|
82 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
227 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Return to work
|
35 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
101 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Perceived time to stop
|
22 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Lack of time
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Pregnancy
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Inadequate milk production
|
11 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Child eating solid foods/teething
|
21 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Reason for discontinuing breastfeeding with last child
Difficulty with breastfeeding
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
|
Support for breastfeeding
Weak
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Support for breastfeeding
Moderate
|
9 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Support for breastfeeding
Strong
|
101 Participants
n=93 Participants
|
94 Participants
n=4 Participants
|
93 Participants
n=27 Participants
|
288 Participants
n=483 Participants
|
|
Support for breastfeeding
Missing Data
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Used an assistive device/nipple shield
Used Device
|
19 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
|
Used an assistive device/nipple shield
Did not use device or no response
|
92 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
273 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
Did not remember
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
0-25%
|
35 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
111 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
25-50%
|
28 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
108 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
50-75%
|
23 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
75-100%
|
13 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours
Missing Data
|
10 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Time from delivery to initial breastfeeding
Did not remember
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Time from delivery to initial breastfeeding
0 to 1 hour
|
90 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
249 Participants
n=483 Participants
|
|
Time from delivery to initial breastfeeding
1 to 3 hours
|
9 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
44 Participants
n=483 Participants
|
|
Time from delivery to initial breastfeeding
4 to 10 hours
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Time from delivery to initial breastfeeding
Greater than 10 hours
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Took a breastfeeding class or received breastfeeding education
Took breastfeeding class
|
62 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
176 Participants
n=483 Participants
|
|
Took a breastfeeding class or received breastfeeding education
Did not take class or no response
|
49 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
156 Participants
n=483 Participants
|
|
Breastfeeding motivational measurement scale
|
119 Score on a scale
n=93 Participants
|
117 Score on a scale
n=4 Participants
|
117 Score on a scale
n=27 Participants
|
118 Score on a scale
n=483 Participants
|
|
Verbal rating score for analgesia satisfaction (0-100)
|
91 score on a scale
n=93 Participants
|
91 score on a scale
n=4 Participants
|
86 score on a scale
n=27 Participants
|
89 score on a scale
n=483 Participants
|
|
Infant birth weight
|
3.54 Kilograms
n=93 Participants
|
3.61 Kilograms
n=4 Participants
|
3.57 Kilograms
n=27 Participants
|
3.56 Kilograms
n=483 Participants
|
|
Mode of Delivery
Vaginal Delivery
|
111 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
328 Participants
n=483 Participants
|
|
Mode of Delivery
Assisted Vaginal Delivery
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Mode of Delivery
Cesarean Delivery
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Breastfeeding at lactation consultant assessment n (%)
Yes
|
98 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
292 Participants
n=483 Participants
|
|
Breastfeeding at lactation consultant assessment n (%)
No
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
Breastfeeding at lactation consultant assessment n (%)
Consultant not available
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Latch
|
2 Score on scale
n=93 Participants
|
2 Score on scale
n=4 Participants
|
2 Score on scale
n=27 Participants
|
2 Score on scale
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Audible swallowing
|
2 Score on scale
n=93 Participants
|
2 Score on scale
n=4 Participants
|
2 Score on scale
n=27 Participants
|
2 Score on scale
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Type of nipple
|
2 Score on scale
n=93 Participants
|
2 Score on scale
n=4 Participants
|
2 Score on scale
n=27 Participants
|
2 Score on scale
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Comfort (breast/nipple)
|
2 Score on scale
n=93 Participants
|
2 Score on scale
n=4 Participants
|
2 Score on scale
n=27 Participants
|
2 Score on scale
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Hold (positioning)
|
1 Score on scale
n=93 Participants
|
1 Score on scale
n=4 Participants
|
1 Score on scale
n=27 Participants
|
1 Score on scale
n=483 Participants
|
|
LATCH score (0-2 for each factor)
Total Score maximum 0-10
|
8.5 Score on scale
n=93 Participants
|
8 Score on scale
n=4 Participants
|
9 Score on scale
n=27 Participants
|
8.5 Score on scale
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours post delivery
0-25%
|
72 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
213 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours post delivery
25-50%
|
19 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours post delivery
50-75%
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Skin-to-skin contact in the first 24 hours post delivery
75-100%
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post deliveryBreastfeeding continuing at 6 weeks after delivery of the baby.
Outcome measures
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
Cumulative Fentanyl Group 1-3
|
|---|---|---|---|---|
|
Breastfeeding at 6 Weeks Post Delivery
Currently breast feeding
|
100 Participants
|
99 Participants
|
102 Participants
|
—
|
|
Breastfeeding at 6 Weeks Post Delivery
Not breastfeeding
|
3 Participants
|
2 Participants
|
6 Participants
|
—
|
|
Breastfeeding at 6 Weeks Post Delivery
Lost to follow up
|
8 Participants
|
8 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months after deliveryBreastfeeding at 3 months after delivery of baby
Outcome measures
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
Cumulative Fentanyl Group 1-3
|
|---|---|---|---|---|
|
Breastfeeding at 3 Months After Delivery
Breastfeeding
|
94 Participants
|
96 Participants
|
93 Participants
|
—
|
|
Breastfeeding at 3 Months After Delivery
Not breastfeeding
|
6 Participants
|
4 Participants
|
12 Participants
|
—
|
|
Breastfeeding at 3 Months After Delivery
Lost to follow up
|
11 Participants
|
9 Participants
|
7 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of epidural catheter removalTotal cumulative dose of fentanyl in micrograms
Outcome measures
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
n=332 Participants
Cumulative Fentanyl Group 1-3
|
|---|---|---|---|---|
|
Cumulative Fentanyl Dose (Micrograms)
|
15 fentalyl dose micrograms
Interval 15.0 to 15.0
|
78 fentalyl dose micrograms
Interval 60.0 to 109.0
|
139 fentalyl dose micrograms
Interval 97.0 to 210.0
|
78 fentalyl dose micrograms
Interval 15.0 to 210.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of epidural catheter removalBlood plasma fentanyl concentraton (nanograms/milliliter).
Outcome measures
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
n=332 Participants
Cumulative Fentanyl Group 1-3
|
|---|---|---|---|---|
|
Plasma Fentanyl Concentration (ng/mL)
|
.01 ng/mL
Interval 0.007 to 0.02
|
.07 ng/mL
Interval 0.05 to 0.09
|
.13 ng/mL
Interval 0.09 to 0.18
|
.07 ng/mL
Interval 0.007 to 0.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after deliveryUmbilical venous blood plasma was analyzed for fentanyl concentration (ng/mL)
Outcome measures
| Measure |
Group 1
n=111 Participants
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.
|
Group 2
n=109 Participants
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.
|
Group 3
n=112 Participants
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.
|
Total
n=332 Participants
Cumulative Fentanyl Group 1-3
|
|---|---|---|---|---|
|
Umbilical Vein Plasma Fentanyl Concentration (ng/mL)
|
.005 ng/mL
Interval 0.005 to 0.1
|
.03 ng/mL
Interval 0.02 to 0.04
|
.06 ng/mL
Interval 0.04 to 0.09
|
.03 ng/mL
Interval 0.005 to 0.09
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=111 participants at risk
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.
|
Group 2
n=109 participants at risk
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.
|
Group 3
n=112 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Spinal headache
|
0.00%
0/111 • 6 Weeks after delivery
Subject contacted at 6 weeks to assess for adverse events.
|
0.00%
0/109 • 6 Weeks after delivery
Subject contacted at 6 weeks to assess for adverse events.
|
0.00%
0/112 • 6 Weeks after delivery
Subject contacted at 6 weeks to assess for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place