NCT04067609

Postoperative Dexamethasone on Post-Cesarean Pain

Postoperative Dexamethasone on Post-Cesarean Pain in Patients Using Medication Assisted Treatment (MAT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Post-Cesarean Pain
• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Dexamethasone	subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
OTHER	placebo	100mL of normal saline (placebo)

Timeline

• Start date: 2020-07-20
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2019-08-26
• Last updated: 2025-05-16
• Results posted: 2025-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study