Cesarean Section Complications, Post-Cesarean Pain
Conditions
Brief summary
Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.
Detailed description
For this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient to have had an epidural placement. Further, Gabapentin, clonidine and ketamine are associated with CNS effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. Lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. Thus, a single administration IV dexamethasone was chosen for this study. Dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. Although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on MAT
Interventions
DRUGDexamethasone
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
OTHERplacebo
100mL of normal saline (placebo)
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
double blind
Intervention model description
a pilot double blind, placebo controlled randomized control trial using 40 subjects
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English-speaking, * History of opioid use disorder with current use of MAT during pregnancy, * Scheduled for cesarean delivery for their current pregnancy for any indication \[examples of elective c-section (decision made for c-section to be performed prior to onset of labor): fetal malpresentation, suspected macrosomia, prior c-section, abnormal placentation, patient preference\], * Negative toxicology screen upon admission to the hospital for their cesarean section, no prior administration of betamethasone for fetal lung maturity within 24h of their scheduled cesarean delivery
Exclusion criteria
* non-english speaking, * screen positive for illicit substance(s) on their admission toxicology screen, * require general anesthesia for their cesarean section due to maternal/fetal indication for non-anticipated urgency (thus no longer 'elective') or failure of adequate intra- operative pain control with spinal anesthesia, * medical history including known cardiovascular disease, heart failure, uncontrolled hypertension, uncontrolled gestational diabetes or uncontrolled pregestational diabetes, active GI bleed or untreated peptic ulcer, * untreated infectious diseases including tuberculosis, systemic candida
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Morphine Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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) | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Patients Receiving Dexamethasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 4.1 | 31.7 years STANDARD_DEVIATION 3.6 | 31.6 years STANDARD_DEVIATION 3.8 |
| Body Mass Index (BMI) at Delivery | 35.9 kg/m^2 STANDARD_DEVIATION 8.3 | 30.2 kg/m^2 STANDARD_DEVIATION 5.2 | 33.1 kg/m^2 STANDARD_DEVIATION 7.3 |
| Breastfeeding No | 1 Participants | 4 Participants | 5 Participants |
| Breastfeeding Yes | 11 Participants | 8 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gravidity | 3.8 pregnancies STANDARD_DEVIATION 1.1 | 3.8 pregnancies STANDARD_DEVIATION 1.5 | 3.8 pregnancies STANDARD_DEVIATION 1.3 |
| Insurance Type Medicaid | 12 Participants | 11 Participants | 23 Participants |
| Insurance Type Private | 0 Participants | 1 Participants | 1 Participants |
| Living Children | 1.3 children STANDARD_DEVIATION 0.6 | 1.6 children STANDARD_DEVIATION 1.1 | 1.4 children STANDARD_DEVIATION 0.9 |
| Medication Type Methadone | 9 Participants | 10 Participants | 19 Participants |
| Medication Type Subutex | 3 Participants | 2 Participants | 5 Participants |
| Number of Prior Cesarean Sections | 1 Cesarean Sections STANDARD_DEVIATION 0.9 | 1.3 Cesarean Sections STANDARD_DEVIATION 1 | 1.1 Cesarean Sections STANDARD_DEVIATION 0.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Mean Pain Score
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
Time frame: 24, 48, 72 and 96 hours post-op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Receiving Dexamethasone | Mean Pain Score | 0-24 hours post-op | 4.1 score on a scale | Standard Deviation 2.9 |
| Patients Receiving Dexamethasone | Mean Pain Score | 25-48 hours post-op | 5.1 score on a scale | Standard Deviation 2.3 |
| Patients Receiving Dexamethasone | Mean Pain Score | 49-72 hours post-op | 4.6 score on a scale | Standard Deviation 2.2 |
| Patients Receiving Dexamethasone | Mean Pain Score | 73-96 hours post-op | 3.9 score on a scale | Standard Deviation 2.4 |
| Placebo | Mean Pain Score | 73-96 hours post-op | 3.8 score on a scale | Standard Deviation 2 |
| Placebo | Mean Pain Score | 0-24 hours post-op | 4.2 score on a scale | Standard Deviation 3.2 |
| Placebo | Mean Pain Score | 49-72 hours post-op | 4.5 score on a scale | Standard Deviation 1.9 |
| Placebo | Mean Pain Score | 25-48 hours post-op | 5.2 score on a scale | Standard Deviation 2 |
Secondary
Change of Morphine Use
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.
Time frame: 24, 48 and 72 hours post-op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Receiving Dexamethasone | Change of Morphine Use | 0-24 hours post-op | 32.3 Morphine milligram equivalents/day | Standard Deviation 30.6 |
| Patients Receiving Dexamethasone | Change of Morphine Use | 25-48 hours post-op | 38.3 Morphine milligram equivalents/day | Standard Deviation 29.6 |
| Patients Receiving Dexamethasone | Change of Morphine Use | 49-72 hours post-op | 14.3 Morphine milligram equivalents/day | Standard Deviation 22.9 |
| Placebo | Change of Morphine Use | 0-24 hours post-op | 34.4 Morphine milligram equivalents/day | Standard Deviation 28.9 |
| Placebo | Change of Morphine Use | 25-48 hours post-op | 44.5 Morphine milligram equivalents/day | Standard Deviation 34.2 |
| Placebo | Change of Morphine Use | 49-72 hours post-op | 20.6 Morphine milligram equivalents/day | Standard Deviation 32 |