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=5 Participants	31.7 years STANDARD_DEVIATION 3.6 • n=7 Participants	31.6 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Gravidity	3.8 pregnancies STANDARD_DEVIATION 1.1 • n=5 Participants	3.8 pregnancies STANDARD_DEVIATION 1.5 • n=7 Participants	3.8 pregnancies STANDARD_DEVIATION 1.3 • n=5 Participants
Living Children	1.3 children STANDARD_DEVIATION 0.6 • n=5 Participants	1.6 children STANDARD_DEVIATION 1.1 • n=7 Participants	1.4 children STANDARD_DEVIATION 0.9 • n=5 Participants
Body Mass Index (BMI) at Delivery	35.9 kg/m^2 STANDARD_DEVIATION 8.3 • n=5 Participants	30.2 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	33.1 kg/m^2 STANDARD_DEVIATION 7.3 • n=5 Participants
Number of Prior Cesarean Sections	1 Cesarean Sections STANDARD_DEVIATION 0.9 • n=5 Participants	1.3 Cesarean Sections STANDARD_DEVIATION 1 • n=7 Participants	1.1 Cesarean Sections STANDARD_DEVIATION 0.9 • n=5 Participants
Insurance Type Medicaid	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Insurance Type Private	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Medication Type Methadone	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Medication Type Subutex	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Breastfeeding Yes	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Breastfeeding No	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24, 48, 72 and 96 hours post-op

Pain 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-op

Comparison 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 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 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 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

Dr Audrey Merriam

Yale School of Medicine

Phone: 203-785-7813

Email: audrey.merriam@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place