Trial Outcomes & Findings for Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries (NCT NCT03470675)
NCT ID: NCT03470675
Last Updated: 2026-04-24
Results Overview
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).
COMPLETED
PHASE4
67 participants
1 week after vaginal delivery
2026-04-24
Participant Flow
Participant milestones
| Measure |
Epidural Saline + IV Saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
26
|
26
|
|
Overall Study
COMPLETED
|
8
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
5
|
Reasons for withdrawal
| Measure |
Epidural Saline + IV Saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
9
|
5
|
Baseline Characteristics
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
Baseline characteristics by cohort
| Measure |
Epidural Saline + IV Saline
n=14 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=26 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=25 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.7 Years
n=2 Participants
|
31.2 Years
n=1 Participants
|
33.9 Years
n=3 Participants
|
33 Years
n=24 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=2 Participants
|
26 Participants
n=1 Participants
|
25 Participants
n=3 Participants
|
65 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
16 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=2 Participants
|
18 Participants
n=1 Participants
|
18 Participants
n=3 Participants
|
44 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Hispanic LatinX
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Not LatinX
|
14 Participants
n=2 Participants
|
25 Participants
n=1 Participants
|
24 Participants
n=3 Participants
|
63 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=2 Participants
|
26 participants
n=1 Participants
|
25 participants
n=3 Participants
|
65 participants
n=24 Participants
|
|
Current Smoker
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=24 Participants
|
|
Gravida
1 Time
|
10 number of participants
n=2 Participants
|
17 number of participants
n=1 Participants
|
14 number of participants
n=3 Participants
|
41 number of participants
n=24 Participants
|
|
Gravida
2 Times
|
1 number of participants
n=2 Participants
|
6 number of participants
n=1 Participants
|
9 number of participants
n=3 Participants
|
15 number of participants
n=24 Participants
|
|
Gravida
Greater than 2 times
|
3 number of participants
n=2 Participants
|
3 number of participants
n=1 Participants
|
2 number of participants
n=3 Participants
|
8 number of participants
n=24 Participants
|
|
Para
No births
|
2 number of participants
n=2 Participants
|
5 number of participants
n=1 Participants
|
3 number of participants
n=3 Participants
|
10 number of participants
n=24 Participants
|
|
Para
1 birth
|
11 number of participants
n=2 Participants
|
17 number of participants
n=1 Participants
|
16 number of participants
n=3 Participants
|
44 number of participants
n=24 Participants
|
|
Para
2 births
|
1 number of participants
n=2 Participants
|
4 number of participants
n=1 Participants
|
6 number of participants
n=3 Participants
|
11 number of participants
n=24 Participants
|
|
Gestational Age (weeks)
|
39.1 Weeks
STANDARD_DEVIATION 1.1 • n=2 Participants
|
39.5 Weeks
STANDARD_DEVIATION .09 • n=1 Participants
|
39.3 Weeks
STANDARD_DEVIATION 1 • n=3 Participants
|
39.3 Weeks
STANDARD_DEVIATION 1 • n=24 Participants
|
|
Labor Type
Spontaneous
|
8 Participants
n=2 Participants
|
16 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
33 Participants
n=24 Participants
|
|
Labor Type
Induction
|
6 Participants
n=2 Participants
|
10 Participants
n=1 Participants
|
16 Participants
n=3 Participants
|
32 Participants
n=24 Participants
|
|
Rupture of Membranes
Spontaneous
|
7 participants
n=2 Participants
|
14 participants
n=1 Participants
|
4 participants
n=3 Participants
|
25 participants
n=24 Participants
|
|
Rupture of Membranes
Artificial
|
7 participants
n=2 Participants
|
12 participants
n=1 Participants
|
21 participants
n=3 Participants
|
40 participants
n=24 Participants
|
|
Fetal Presentation
Cephalic Presentation
|
11 Participants
n=2 Participants
|
17 Participants
n=1 Participants
|
18 Participants
n=3 Participants
|
46 Participants
n=24 Participants
|
|
Fetal Presentation
Vertex Presentation
|
3 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
19 Participants
n=24 Participants
|
|
Prostaglandin Cervical Ripening
|
3 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
8 Participants
n=3 Participants
|
16 Participants
n=24 Participants
|
|
Oxytocin Augmentation
Oxytocin augmentation
|
12 Participants
n=2 Participants
|
25 Participants
n=1 Participants
|
24 Participants
n=3 Participants
|
61 Participants
n=24 Participants
|
|
Oxytocin Augmentation
No oxytocin augmentation
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=24 Participants
|
|
1st Stage of Labor (minutes)
|
734 Minutes
n=2 Participants
|
510 Minutes
n=1 Participants
|
540 Minutes
n=3 Participants
|
579 Minutes
n=24 Participants
|
|
2nd stage of labor (minutes)
30-60 minutes
|
5 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
11 Participants
n=3 Participants
|
25 Participants
n=24 Participants
|
|
2nd stage of labor (minutes)
61-120 Minutes
|
2 Participants
n=2 Participants
|
8 Participants
n=1 Participants
|
9 Participants
n=3 Participants
|
19 Participants
n=24 Participants
|
|
2nd stage of labor (minutes)
Greater than 120 Minutes
|
7 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
21 Participants
n=24 Participants
|
|
Delivery Mode
Vaginal Unassisted
|
8 Participants
n=2 Participants
|
16 Participants
n=1 Participants
|
11 Participants
n=3 Participants
|
35 Participants
n=24 Participants
|
|
Delivery Mode
Vaginal Operative
|
6 Participants
n=2 Participants
|
10 Participants
n=1 Participants
|
14 Participants
n=3 Participants
|
30 Participants
n=24 Participants
|
|
Operative Type
Forceps
|
4 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
12 Participants
n=3 Participants
|
25 Participants
n=24 Participants
|
|
Operative Type
Vacuum
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=24 Participants
|
|
Degree Perineal Laceration
3rd degree laceration
|
13 Participants
n=2 Participants
|
20 Participants
n=1 Participants
|
22 Participants
n=3 Participants
|
55 Participants
n=24 Participants
|
|
Degree Perineal Laceration
4th degree laceration
|
1 Participants
n=2 Participants
|
6 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=24 Participants
|
|
Suture Repair Style
Uninterrupted
|
4 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
20 Participants
n=24 Participants
|
|
Suture Repair Style
Interrupted
|
2 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
6 Participants
n=3 Participants
|
12 Participants
n=24 Participants
|
|
Suture Repair Style
Interrupted + Uninterrupted
|
8 Participants
n=2 Participants
|
13 Participants
n=1 Participants
|
12 Participants
n=3 Participants
|
33 Participants
n=24 Participants
|
|
Fetal Weight
|
3450 Grams
STANDARD_DEVIATION 478 • n=2 Participants
|
3410 Grams
STANDARD_DEVIATION 457 • n=1 Participants
|
3555 Grams
STANDARD_DEVIATION 417 • n=3 Participants
|
3470 Grams
STANDARD_DEVIATION 456 • n=24 Participants
|
|
Plan to Breastfeed
|
14 Participants
n=2 Participants
|
25 Participants
n=1 Participants
|
24 Participants
n=3 Participants
|
63 Participants
n=24 Participants
|
|
NRS Pain Score at Study Drug Administration
|
2 Score on Scale
n=2 Participants
|
0 Score on Scale
n=1 Participants
|
2 Score on Scale
n=3 Participants
|
1 Score on Scale
n=24 Participants
|
|
ACRI Questionnaire
|
.5 score on scale
n=2 Participants
|
1 score on scale
n=1 Participants
|
5 score on scale
n=3 Participants
|
2 score on scale
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 week after vaginal deliveryPopulation: Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=13 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.
|
2.4 score on a scale
Interval 1.7 to 3.1
|
3.5 score on a scale
Interval 2.3 to 4.7
|
2.7 score on a scale
Interval 2.0 to 3.4
|
SECONDARY outcome
Timeframe: Day 1 after deliveryPopulation: Epidural Morphine 3 mg + saline group 3 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Perineal pain day 1 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=14 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=23 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain
|
12.9 score on a scale
Interval 10.0 to 15.8
|
14.4 score on a scale
Interval 10.0 to 18.9
|
10.4 score on a scale
Interval 7.9 to 12.9
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Perineal pain day 7 after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=13 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain
|
8.9 score on a scale
Interval 6.6 to 11.2
|
9.5 score on a scale
Interval 6.9 to 12.1
|
9.4 score on a scale
Interval 6.2 to 12.7
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment (poor) to 95 high maternal infant attachment (good).
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=13 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Assessment of Maternal-infant Bonding
|
83.8 Score on a scale
Interval 81.8 to 85.9
|
82.5 Score on a scale
Interval 78.4 to 86.7
|
79.1 Score on a scale
Interval 73.9 to 84.2
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Presence of postpartum depression 7 days after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low- 30 high. High scores indicate potential for depression.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=13 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Presence of Postpartum Depression
|
6.7 score on a scale
Interval 4.9 to 9.4
|
5.7 score on a scale
Interval 2.9 to 8.6
|
7.0 score on a scale
Interval 4.7 to 9.4
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Epidural saline + IV saline group 1 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 1 lost to follow up
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=24 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=13 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Brief Pain Inventory (BPI-ST Short Form) Current Pain
|
2.2 score on a scale
Interval 1.6 to 2.9
|
3.0 score on a scale
Interval 2.2 to 3.8
|
2.3 score on a scale
Interval 1.6 to 3.1
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
Presence of postpartum depression 6 weeks after delivery determined by using the Edinburgh Postnatal Depression Scale questionnaire. The questionnaire uses 10 questions scored 0 low to 3 high for a total score of 0 low 30 high. High scores indicate potential for depression.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=22 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Presence of Postpartum Depression
|
4.8 score on a scale
Interval 3.3 to 6.3
|
5.1 score on a scale
Interval 2.6 to 7.6
|
4.7 score on a scale
Interval 2.8 to 6.6
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
Perineal pain 6 weeks after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=22 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain
|
3.8 score on a scale
Interval 1.9 to 5.7
|
1.7 score on a scale
Interval 0.3 to 3.1
|
5.2 score on a scale
Interval 1.4 to 9.0
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=22 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Assessment of Maternal-infant Bonding
|
85.0 Score on a scale
Interval 82.4 to 87.7
|
83.2 Score on a scale
Interval 78.8 to 87.6
|
80.9 Score on a scale
Interval 76.8 to 85.1
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 7 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=22 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=19 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Brief Pain Inventory (BPI-ST Short Form) Current Pain
|
.7 score on a scale
Interval 0.1 to 1.3
|
.3 score on a scale
Interval 0.0 to 0.6
|
.5 score on a scale
Interval 0.1 to 1.0
|
SECONDARY outcome
Timeframe: 3 months after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up
Perineal pain 3 months after delivery using the McGill Pain Questionnaire (MPQ). This is a 15 question survey describing pain on a scale. The scale is scored 0 no pain and 3 severe pain.Combined score 0 low and 45 high pain.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain
|
1 score on a scale
Interval 0.4 to 1.7
|
.8 score on a scale
Interval 0.3 to 2.0
|
3.2 score on a scale
Interval 0.8 to 5.6
|
SECONDARY outcome
Timeframe: 3 months after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up
Assessment of maternal infant bonding using the Maternal Postnatal Attachment Scale (MPAS) questionnaire. 19 total question survey which is scored 1= low attachment and 5 = high attachment for each question. Total scores 19 low attachment to 95 high maternal infant attachment.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Assessment of Maternal-infant Bonding
|
4.4 Scores on a scale
Interval 3.1 to 5.7
|
4.0 Scores on a scale
Interval 2.3 to 5.8
|
3.6 Scores on a scale
Interval 2.0 to 5.3
|
SECONDARY outcome
Timeframe: 3 months after deliveryPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up
Female Sexual Function Index questionnaire (FSFI).This is a 19 question survey which is scored 2 low sexual function to 36 high sexual function.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Female Sexual Function
|
14.8 Score on scale 2 low 36 high
Interval 11.1 to 18.5
|
13 Score on scale 2 low 36 high
Interval 8.4 to 17.6
|
14.2 Score on scale 2 low 36 high
Interval 10.2 to 18.2
|
SECONDARY outcome
Timeframe: 3 months after deliveryPopulation: Epidural saline + IV saline group 4 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
Part 1 of the 7 question survey (Current Pain). 0 no pain -10 worst pain you can imagine scale.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Brief Pain Inventory (BPI-ST Short Form) Current Pain
|
0.0 score on a scale
Interval 0.0 to 0.2
|
.2 score on a scale
Interval 0.2 to 0.7
|
.6 score on a scale
Interval 0.0 to 1.1
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher physical function.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Physical Function Question Only)
|
54.8 T score
Interval 52.9 to 56.6
|
52.9 T score
Interval 48.4 to 57.5
|
54.8 T score
Interval 52.7 to 56.8
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 anxiety rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher anxiety.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Anxiety Function Question Only)
|
46.7 T score
Interval 43.9 to 49.6
|
44.8 T score
Interval 39.3 to 50.3
|
45.3 T score
Interval 43.0 to 53.6
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher depression.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Depressive Symptoms Question Only)
|
43.6 T score
Interval 41.2 to 45.9
|
45 T score
Interval 42.1 to 48.0
|
43 T score
Interval 40.9 to 45.2
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of fatigue.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Fatigue Question Only)
|
50.0 T score
Interval 47.9 to 53.2
|
45.9 T score
Interval 41.6 to 50.3
|
48.1 T score
Interval 44.1 to 52.1
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of sleep disturbance.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Sleep Disturbance Question Only)
|
54.8 T score
Interval 51.1 to 58.6
|
58.3 T score
Interval 55.6 to 61.0
|
56.0 T score
Interval 54.0 to 57.9
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates higher level of social function.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Social Function Question Only)
|
55.3 T score
Interval 52.4 to 58.2
|
55.8 T score
Interval 50.7 to 61.0
|
53.8 T score
Interval 50.3 to 57.3
|
SECONDARY outcome
Timeframe: 3 monthPopulation: Epidural saline + IV saline group 3 lost to follow up Epidural Morphine 3 mg + saline group 6 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 3 lost to follow up
29 question recovery survey, 28 questions scored 1 low to 5 high and one question scored 0-10 for pain. Low combined total score (poor) 28 High combine 150 total score (good).The PROMIS-29 questionnaire is then scored by summing raw item responses (1-5 scale) for seven domains (four questions each) and a 0-10 pain rating, then converting these to T-scores (mean=50, SD=10). A higher T-score indicates a higher level of pain interference.
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=11 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=20 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Promis 29 Profile (Pain Interference Question Only)
|
43.5 T score
Interval 41.7 to 45.2
|
44 T score
Interval 40.6 to 47.5
|
43 T score
Interval 41.4 to 44.4
|
SECONDARY outcome
Timeframe: 1 year after deliveryPopulation: Epidural saline + IV saline group 6 lost to follow up Epidural Morphine 3 mg + saline group 9 lost to follow up Epidural Morphine 3 mg + ketamine .3 mg/kg 4 lost to follow up
Perineal pain 1 year after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good) and 10 highest pain (poor).
Outcome measures
| Measure |
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=21 Participants
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
Epidural Saline + IV Saline
n=8 Participants
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=17 Participants
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
|---|---|---|---|
|
Perineal Pain
|
.3 score on a scale
Interval 0.1 to 0.5
|
.1 score on a scale
Interval 0.1 to 0.2
|
.5 score on a scale
Interval 0.1 to 1.1
|
Adverse Events
Epidural Saline + IV Saline
Epidural Morphine 3 mg + IV Saline
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epidural Saline + IV Saline
n=14 participants at risk
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
Epidural saline + IV saline: Sterile saline injection in the epidural catheter and in the intravenous catheter
|
Epidural Morphine 3 mg + IV Saline
n=26 participants at risk
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
Epidural morphine 3 mg + IV saline: Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
|
Epidural Morphine 3 mg + IV Ketamine 0.3 mg/kg
n=25 participants at risk
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg: Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • 48 Hours after delivery of baby.
|
3.8%
1/26 • Number of events 1 • 48 Hours after delivery of baby.
|
8.0%
2/25 • Number of events 2 • 48 Hours after delivery of baby.
|
|
General disorders
Hives
|
0.00%
0/14 • 48 Hours after delivery of baby.
|
3.8%
1/26 • Number of events 1 • 48 Hours after delivery of baby.
|
0.00%
0/25 • 48 Hours after delivery of baby.
|
|
General disorders
Wound Problems
|
7.1%
1/14 • Number of events 1 • 48 Hours after delivery of baby.
|
0.00%
0/26 • 48 Hours after delivery of baby.
|
0.00%
0/25 • 48 Hours after delivery of baby.
|
|
Cardiac disorders
Hypotension
|
14.3%
2/14 • Number of events 2 • 48 Hours after delivery of baby.
|
11.5%
3/26 • Number of events 3 • 48 Hours after delivery of baby.
|
8.0%
2/25 • Number of events 2 • 48 Hours after delivery of baby.
|
|
General disorders
Pruritus
|
0.00%
0/14 • 48 Hours after delivery of baby.
|
11.5%
3/26 • Number of events 3 • 48 Hours after delivery of baby.
|
8.0%
2/25 • Number of events 2 • 48 Hours after delivery of baby.
|
|
General disorders
Fever
|
0.00%
0/14 • 48 Hours after delivery of baby.
|
7.7%
2/26 • Number of events 2 • 48 Hours after delivery of baby.
|
4.0%
1/25 • Number of events 1 • 48 Hours after delivery of baby.
|
|
Musculoskeletal and connective tissue disorders
Back Ache
|
7.1%
1/14 • Number of events 1 • 48 Hours after delivery of baby.
|
23.1%
6/26 • Number of events 6 • 48 Hours after delivery of baby.
|
16.0%
4/25 • Number of events 4 • 48 Hours after delivery of baby.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • 48 Hours after delivery of baby.
|
7.7%
2/26 • Number of events 2 • 48 Hours after delivery of baby.
|
12.0%
3/25 • Number of events 3 • 48 Hours after delivery of baby.
|
Additional Information
Paul C. Fitzgerald, RN, BSN, MS
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place