Postoperative Dexamethasone on Post-Cesarean Pain

NCT ID: NCT04067609

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2024-04-01

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

Conditions

Post-Cesarean Pain; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

patients receiving dexamethasone

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

100mL of normal saline (placebo)

Interventions

Dexamethasone

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

Intervention Type: DRUG

placebo

100mL of normal saline (placebo)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Wesevich, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000025968

Identifier Type: -

Identifier Source: org_study_id