Trial Outcomes & Findings for Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management (NCT NCT02605187)
NCT ID: NCT02605187
Last Updated: 2018-10-16
Results Overview
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
0-24 and 24-48 hour postoperative periods
Results posted on
2018-10-16
Participant Flow
Participant milestones
| Measure |
No Choice
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
21
|
83
|
16
|
|
Overall Study
COMPLETED
|
32
|
19
|
72
|
15
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
11
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Baseline characteristics by cohort
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35 years
n=99 Participants
|
37 years
n=107 Participants
|
34 years
n=206 Participants
|
33 years
n=7 Participants
|
35 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
138 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
46 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
28 kg/m^2
n=99 Participants
|
28 kg/m^2
n=107 Participants
|
29 kg/m^2
n=206 Participants
|
30 kg/m^2
n=7 Participants
|
28 kg/m^2
n=31 Participants
|
|
Gestational age (week)
|
39.0 week
n=99 Participants
|
39.1 week
n=107 Participants
|
39.0 week
n=206 Participants
|
39.0 week
n=7 Participants
|
39.0 week
n=31 Participants
|
|
Education
High school
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Education
Some college
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
|
Education
BA or equivalent
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Education
Graduate Degree
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
|
Nulliparous
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Previous Cesarean Delivery
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
91 Participants
n=31 Participants
|
|
Language
English
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
123 Participants
n=31 Participants
|
|
Language
Other
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 0-24 and 24-48 hour postoperative periodsPopulation: Participants who completed the protocol are included in the analysis.
Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Opioid Consumption in the 0-48 Hour Study Periods.
0-24 hours
|
10 milligram morphine equivalents (MMEQ)
Interval 0.0 to 15.0
|
5 milligram morphine equivalents (MMEQ)
Interval 0.0 to 20.0
|
10 milligram morphine equivalents (MMEQ)
Interval 0.0 to 25.0
|
5 milligram morphine equivalents (MMEQ)
Interval 0.0 to 30.0
|
|
Opioid Consumption in the 0-48 Hour Study Periods.
24-48 hours
|
10 milligram morphine equivalents (MMEQ)
Interval 0.0 to 30.0
|
0 milligram morphine equivalents (MMEQ)
Interval 0.0 to 10.0
|
5 milligram morphine equivalents (MMEQ)
Interval 0.0 to 20.0
|
30 milligram morphine equivalents (MMEQ)
Interval 10.0 to 40.0
|
PRIMARY outcome
Timeframe: 3, 6, 12, 24, 36 and 48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Pain Scores
Pain at rest at 3 hours
|
1.6 units on a scale
Standard Deviation 2.0
|
1.8 units on a scale
Standard Deviation 2.0
|
1.9 units on a scale
Standard Deviation 2.1
|
2.2 units on a scale
Standard Deviation 2.2
|
|
Pain Scores
Pain at movement at 3 hours
|
3.2 units on a scale
Standard Deviation 2.9
|
3.4 units on a scale
Standard Deviation 2.5
|
3.2 units on a scale
Standard Deviation 2.7
|
4.1 units on a scale
Standard Deviation 2.5
|
|
Pain Scores
Pain at rest at 6 hours
|
2.3 units on a scale
Standard Deviation 2.3
|
2.7 units on a scale
Standard Deviation 1.9
|
2.2 units on a scale
Standard Deviation 1.8
|
1.5 units on a scale
Standard Deviation 1.6
|
|
Pain Scores
Pain at movement at 6 hours
|
4.0 units on a scale
Standard Deviation 2.7
|
4.4 units on a scale
Standard Deviation 2.4
|
3.8 units on a scale
Standard Deviation 2.4
|
3.8 units on a scale
Standard Deviation 2.4
|
|
Pain Scores
Pain at rest at 12 hours
|
1.5 units on a scale
Standard Deviation 1.7
|
2.1 units on a scale
Standard Deviation 1.7
|
1.9 units on a scale
Standard Deviation 1.8
|
1.7 units on a scale
Standard Deviation 1.7
|
|
Pain Scores
Pain at movement at 12 hours
|
3.0 units on a scale
Standard Deviation 2.3
|
4.7 units on a scale
Standard Deviation 1.5
|
3.6 units on a scale
Standard Deviation 2.0
|
3.2 units on a scale
Standard Deviation 2.1
|
|
Pain Scores
Pain at rest at 24 hours
|
2.2 units on a scale
Standard Deviation 1.9
|
1.9 units on a scale
Standard Deviation 1.0
|
2.2 units on a scale
Standard Deviation 1.7
|
2.3 units on a scale
Standard Deviation 1.7
|
|
Pain Scores
Pain at movement at 24 hours
|
4.5 units on a scale
Standard Deviation 2.3
|
4.1 units on a scale
Standard Deviation 1.5
|
4.3 units on a scale
Standard Deviation 2.0
|
3.6 units on a scale
Standard Deviation 1.8
|
|
Pain Scores
Pain at rest tat 36 hours
|
1.5 units on a scale
Standard Deviation 1.6
|
1.7 units on a scale
Standard Deviation 1.3
|
2.6 units on a scale
Standard Deviation 2.0
|
3.1 units on a scale
Standard Deviation 2.4
|
|
Pain Scores
Pain at movement at 36 hours
|
3.5 units on a scale
Standard Deviation 2.2
|
4.0 units on a scale
Standard Deviation 2.1
|
4.5 units on a scale
Standard Deviation 2.0
|
4.8 units on a scale
Standard Deviation 1.8
|
|
Pain Scores
Pain at rest at 48 hours
|
1.7 units on a scale
Standard Deviation 1.6
|
2.0 units on a scale
Standard Deviation 1.9
|
2.0 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 2.2
|
|
Pain Scores
Pain at movement at 48 hours
|
3.5 units on a scale
Standard Deviation 1.9
|
3.9 units on a scale
Standard Deviation 1.8
|
3.6 units on a scale
Standard Deviation 1.8
|
4.8 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Count of participants who need opioid use through 48 hours after delivery.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Count of Participants Who Need Opioid Use
24-48 hours after delivery
|
23 Participants
|
8 Participants
|
42 Participants
|
14 Participants
|
|
Count of Participants Who Need Opioid Use
0-24 hours after delivery
|
27 Participants
|
14 Participants
|
50 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Count of participants with pruritus through 48 hours after delivery.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Count of Participants With Presence of Pruritus
0-24 hours after delivery
|
27 Participants
|
11 Participants
|
63 Participants
|
13 Participants
|
|
Count of Participants With Presence of Pruritus
24-48 hours after delivery
|
12 Participants
|
3 Participants
|
29 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 and 48 hours following deliveryPopulation: Participants who completed the protocol are included in the analysis.
Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Pruritus Score at 24 and 48 After Delivery
24 hours after delivery
|
4.2 units on a scale
Standard Deviation 2.7
|
1.7 units on a scale
Standard Deviation 2.3
|
3.7 units on a scale
Standard Deviation 2.5
|
4.5 units on a scale
Standard Deviation 2.7
|
|
Pruritus Score at 24 and 48 After Delivery
48 hours after delivery
|
0.8 units on a scale
Standard Deviation 1.3
|
0.2 units on a scale
Standard Deviation 0.6
|
1.0 units on a scale
Standard Deviation 1.8
|
1.1 units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Count of participants who need medical treatment of pruritus during first 48 hours after delivery.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Count of Participants Who Need Medical Treatment of Pruritus
0-24 hours after delivery
|
7 Participants
|
2 Participants
|
12 Participants
|
3 Participants
|
|
Count of Participants Who Need Medical Treatment of Pruritus
24-48 hours after delivery
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Count of participants with nausea through 48 hours after delivery.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Counts of Participants With Presence of Nausea
|
11 Participants
|
7 Participants
|
33 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Nausea Score Score at 24 and 48 After Delivery
0-24 hours after delivery
|
1.3 units on a scale
Standard Deviation 2.4
|
1.1 units on a scale
Standard Deviation 2.0
|
1.5 units on a scale
Standard Deviation 2.4
|
1.8 units on a scale
Standard Deviation 1.7
|
|
Nausea Score Score at 24 and 48 After Delivery
24-48 hours after delivery
|
0.3 units on a scale
Standard Deviation 0.9
|
0.2 units on a scale
Standard Deviation 0.5
|
0.2 units on a scale
Standard Deviation 0.7
|
0.2 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Counts of participants who need medical treatment of nausea through 48 hours after delivery.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Counts of Participants Who Need Medical Treatment for Nausea
0-24 hours after delivery
|
8 Participants
|
9 Participants
|
20 Participants
|
9 Participants
|
|
Counts of Participants Who Need Medical Treatment for Nausea
24-48 hours after delivery
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-24 and 24-48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Average Number of Vomiting Episodes After Delivery
0-24 hours after delivery
|
0.6 vomiting episodes
Standard Deviation 1.5
|
0.3 vomiting episodes
Standard Deviation 1.0
|
0.5 vomiting episodes
Standard Deviation 1.4
|
1.3 vomiting episodes
Standard Deviation 2.0
|
|
Average Number of Vomiting Episodes After Delivery
24-48 hours after delivery
|
0 vomiting episodes
Standard Deviation 0
|
0 vomiting episodes
Standard Deviation 0
|
0 vomiting episodes
Standard Deviation 0
|
0 vomiting episodes
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Delivery through discharge (average 4 days)Population: Participants who completed the protocol are included in the analysis.
Minutes from delivery until discharge.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Time to Discharge
|
4771.9 minutes
Standard Deviation 1231.2
|
4652.1 minutes
Standard Deviation 1006.7
|
5278.9 minutes
Standard Deviation 1410.3
|
5722.3 minutes
Standard Deviation 1391.9
|
SECONDARY outcome
Timeframe: 24 and 48 hours after deliveryPopulation: Participants who completed the protocol are included in the analysis.
Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.
Outcome measures
| Measure |
No Choice
n=32 Participants
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 Participants
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 Participants
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 Participants
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Patient Overall Satisfaction With Postoperative Analgesia
24 hours after delivery
|
87.2 units on a scale
Standard Deviation 12.7
|
90.3 units on a scale
Standard Deviation 10.4
|
94.1 units on a scale
Standard Deviation 9.5
|
93.3 units on a scale
Standard Deviation 7.7
|
|
Patient Overall Satisfaction With Postoperative Analgesia
48 hours after delivery
|
89.9 units on a scale
Standard Deviation 10.6
|
92.6 units on a scale
Standard Deviation 9.7
|
91.2 units on a scale
Standard Deviation 15.1
|
89.3 units on a scale
Standard Deviation 14.0
|
Adverse Events
No Choice
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Choice: Low Protocol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Choice: Medium Protocol
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Choice: High Protocol
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Choice
n=32 participants at risk
No choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
No choice given: Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: Low Protocol
n=19 participants at risk
Choice given low dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (low): Intrathecal morphine dose 50mcg
|
Choice: Medium Protocol
n=72 participants at risk
Choice given medium dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Morphine (med): Intrathecal morphine dose 150mcg
|
Choice: High Protocol
n=15 participants at risk
Choice given high dose intrathecal morphine acetaminophen po q6h ibuprofen po q6h gabapentin po one time dose
Choice given: Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
Ibuprofen: Ibuprofen 600mg po q6h
Acetaminophen: Acetaminophen 650mg po q6h
Gabapentin: Gabapentin 600mg po one time within 1 hour of delivery
Morphine (high): Intrathecal morphine 300mcg
|
|---|---|---|---|---|
|
Surgical and medical procedures
Pain due to Bakri balloon and vag pack
|
3.1%
1/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Pregnancy, puerperium and perinatal conditions
received methergine for Postpartum hemorrhage
|
3.1%
1/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
6.7%
1/15 • Delivery to discharge (average 4 days)
|
|
Skin and subcutaneous tissue disorders
Itching rash on abdomen
|
3.1%
1/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Nervous system disorders
Migrain
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
5.3%
1/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Pregnancy, puerperium and perinatal conditions
Severe pre E diagnosed postpartum
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Pregnancy, puerperium and perinatal conditions
misoprostol used at delivery
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
General disorders
Vomit
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Pregnancy, puerperium and perinatal conditions
preeclampsia
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
General disorders
Surrogate
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
Infections and infestations
Urinary Tract Infections
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
1.4%
1/72 • Delivery to discharge (average 4 days)
|
0.00%
0/15 • Delivery to discharge (average 4 days)
|
|
General disorders
Used On Q pump
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
6.7%
1/15 • Delivery to discharge (average 4 days)
|
|
General disorders
Extended stay
|
0.00%
0/32 • Delivery to discharge (average 4 days)
|
0.00%
0/19 • Delivery to discharge (average 4 days)
|
0.00%
0/72 • Delivery to discharge (average 4 days)
|
6.7%
1/15 • Delivery to discharge (average 4 days)
|
Additional Information
Dr. Brendan Carvalho
Stanford University School of Medicine
Phone: 650-861-8607
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place