Skip to main content
Clinical Trials/NCT03678870
NCT03678870CompletedNot Applicable

Discharge Opioid Education to Decrease Opioid Use After Cesarean

Vanderbilt University Medical Center2 sites in 1 country196 target enrollmentStarted: September 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
196
Locations
2
Primary Endpoint
Opioid Use

Study Overview

Brief Summary

Background: The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion and higher opioid use after surgery has been associated with an increased risk of chronic opioid use. Reducing the amount of opioid used after cesarean delivery may decrease the risk of chronic opioid use and will help towards better estimating and reducing the amount of opioids prescribed at discharge.

Objective: To to compare discharge opioid education to standard care to ascertain whether opioid education reduces opioid use after hospital discharge

Detailed Description

Background: The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion and higher opioid use after surgery has been associated with an increased risk of chronic opioid use. Reducing the amount of opioid used after cesarean delivery may decrease the risk of chronic opioid use and will help towards better estimating and reducing the amount of opioids prescribed at discharge.

Objective: To to compare discharge opioid education to standard care to ascertain whether opioid education reduces opioid use after hospital discharge

Preliminary Data: Our soon to be published study (Obstetrics & Gynecology Journal) found that 30% of women used all their opioids after discharge for cesarean delivery because they "were following directions" and not because they had pain.

Enrollment & Randomization

Enrollment

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Women 18-45 years old
  • Women undergoing cesarean delivery at VUMC

Exclusion Criteria

  • Major post-surgical complications:
  • cesarean hysterectomy, bowel or bladder injury, reoperation, ICU admission, wound infection or separation
  • Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for > 7 days during pregnancy.
  • Women who do not speak English

Outcomes

Primary Outcomes

Opioid Use

Time Frame: 6 weeks postpartum

Median number of tablets of hydrocodone-acetaminophen used after hospital discharge

Secondary Outcomes

  • Disposed of Opioids Correctly(6 weeks postpartum)
  • Analgesic Quiz Score(6 weeks postpartum)
  • Additional Prescriptions(6 weeks postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Osmundson

Assistant Professor, Ob/Gyn

Vanderbilt University Medical Center

Study Sites (2)

Loading locations...

Similar Trials