Clinical trial NCT04067609: Postoperative Dexamethasone on Post-Cesarean Pain
Official title: Postoperative Dexamethasone on Post-Cesarean Pain in Patients Using Medication Assisted Treatment (MAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Cesarean Pain
Cesarean Section Complications
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a pilot double blind, placebo controlled randomized control trial using 40 subjects
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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

Primary outcomes:
measure: Mean Pain Score
timeFrame: 24, 48, 72 and 96 hours post-op
Secondary outcomes:
measure: Change of Morphine Use
timeFrame: 24, 48 and 72 hours post-op
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Victoria Wesevich, MD
role: PRINCIPAL_INVESTIGATOR
References: