Postoperative Dexamethasone on Post-Cesarean Pain

Yale University

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Post-Cesarean Pain

Treatments: Drug: Dexamethasone; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04067609

2000025968

000

Details and patient eligibility

About

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.

Full 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

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups, including a placebo group

patients receiving dexamethasone

Experimental group

Description:

subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline

Treatment:

Drug: Dexamethasone

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo