Postoperative Dexamethasone on Post-Cesarean Pain

Phase 4

Recruiting

• Conditions: Post-Cesarean Pain; Cesarean Section Complications
• Interventions: Other: placebo; Drug: Dexamethasone

• Registration Number: NCT04067609
• Lead Sponsor: Yale University

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

Study Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-26
• Study Start: 2020-07-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	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
patients receiving dexamethasone	Dexamethasone	subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline

Primary Outcome Measures

Name	Time	Method
improvement in pain score	within 72 hours of surgery	Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).

Secondary Outcome Measures

Name	Time	Method
change of morphine use	within 72 hours of surgery	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.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States