Postoperative Dexamethasone on Post-Cesarean Pain

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04067609
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
22.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a pilot double blind, placebo controlled randomized control trial using 40 subjectsa pilot double blind, placebo controlled randomized control trial using 40 subjects
Masking:
Single (Participant)
Masking Description:
double blind
Primary Purpose:
Supportive Care
Official Title:
Postoperative Dexamethasone on Post-Cesarean Pain in Patients Using Medication Assisted Treatment (MAT)
Actual Study Start Date :
Jul 20, 2020
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: patients receiving dexamethasone

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

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

Placebo Comparator: 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

Other: placebo
100mL of normal saline (placebo)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Yale New Haven HospitalNew HavenConnecticutUnited States06510

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Victoria Wesevich, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04067609
Other Study ID Numbers:
  • 2000025968
First Posted:
Aug 26, 2019
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021