Overview

Postoperative Dexamethasone on Post-Cesarean Pain

Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yale University
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Criteria
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