Trial Outcomes & Findings for Postoperative Dexamethasone on Post-Cesarean Pain (NCT NCT04067609)
NCT ID: NCT04067609
Last Updated: 2025-05-16
Results Overview
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
24, 48, 72 and 96 hours post-op
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
Patients Receiving Dexamethasone
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
|
Placebo
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
placebo: 100mL of normal saline (placebo)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postoperative Dexamethasone on Post-Cesarean Pain
Baseline characteristics by cohort
| Measure |
Patients Receiving Dexamethasone
n=12 Participants
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
|
Placebo
n=12 Participants
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
placebo: 100mL of normal saline (placebo)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
31.7 years
STANDARD_DEVIATION 3.6 • n=107 Participants
|
31.6 years
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Gravidity
|
3.8 pregnancies
STANDARD_DEVIATION 1.1 • n=99 Participants
|
3.8 pregnancies
STANDARD_DEVIATION 1.5 • n=107 Participants
|
3.8 pregnancies
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Living Children
|
1.3 children
STANDARD_DEVIATION 0.6 • n=99 Participants
|
1.6 children
STANDARD_DEVIATION 1.1 • n=107 Participants
|
1.4 children
STANDARD_DEVIATION 0.9 • n=206 Participants
|
|
Body Mass Index (BMI) at Delivery
|
35.9 kg/m^2
STANDARD_DEVIATION 8.3 • n=99 Participants
|
30.2 kg/m^2
STANDARD_DEVIATION 5.2 • n=107 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 7.3 • n=206 Participants
|
|
Number of Prior Cesarean Sections
|
1 Cesarean Sections
STANDARD_DEVIATION 0.9 • n=99 Participants
|
1.3 Cesarean Sections
STANDARD_DEVIATION 1 • n=107 Participants
|
1.1 Cesarean Sections
STANDARD_DEVIATION 0.9 • n=206 Participants
|
|
Insurance Type
Medicaid
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Insurance Type
Private
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Medication Type
Methadone
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Medication Type
Subutex
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Breastfeeding
Yes
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Breastfeeding
No
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24, 48, 72 and 96 hours post-opPain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
Outcome measures
| Measure |
Patients Receiving Dexamethasone
n=12 Participants
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
|
Placebo
n=12 Participants
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
placebo: 100mL of normal saline (placebo)
|
|---|---|---|
|
Mean Pain Score
0-24 hours post-op
|
4.1 score on a scale
Standard Deviation 2.9
|
4.2 score on a scale
Standard Deviation 3.2
|
|
Mean Pain Score
25-48 hours post-op
|
5.1 score on a scale
Standard Deviation 2.3
|
5.2 score on a scale
Standard Deviation 2.0
|
|
Mean Pain Score
49-72 hours post-op
|
4.6 score on a scale
Standard Deviation 2.2
|
4.5 score on a scale
Standard Deviation 1.9
|
|
Mean Pain Score
73-96 hours post-op
|
3.9 score on a scale
Standard Deviation 2.4
|
3.8 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 24, 48 and 72 hours post-opComparison of total morphine dose equivalents used by the patient during this period will be examined. The total morphine dose equivalents will be calculated from the total narcotic dose and appropriate conversion (i.e. dilaudid dose to morphine dose equivalents). This will be calculated as a total daily dose for the hospital stay and an average dose/d over the entire hospital stay. These 2 separate calculations will be used because it is presumed that narcotic use will decrease with each day post-op. Calculating an average dose/d over the entire hospital stay will account for women who are discharged on different postoperative days.
Outcome measures
| Measure |
Patients Receiving Dexamethasone
n=12 Participants
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
Dexamethasone: subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
|
Placebo
n=12 Participants
100mL of normal saline (placebo) immediately upon the subjects' arrival to the Post Anesthesia Care Unit (PACU) after leaving the operating room from their scheduled c-section
placebo: 100mL of normal saline (placebo)
|
|---|---|---|
|
Change of Morphine Use
0-24 hours post-op
|
32.3 Morphine milligram equivalents/day
Standard Deviation 30.6
|
34.4 Morphine milligram equivalents/day
Standard Deviation 28.9
|
|
Change of Morphine Use
25-48 hours post-op
|
38.3 Morphine milligram equivalents/day
Standard Deviation 29.6
|
44.5 Morphine milligram equivalents/day
Standard Deviation 34.2
|
|
Change of Morphine Use
49-72 hours post-op
|
14.3 Morphine milligram equivalents/day
Standard Deviation 22.9
|
20.6 Morphine milligram equivalents/day
Standard Deviation 32
|
Adverse Events
Patients Receiving Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place