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Clinical Trials/NCT03168425
NCT03168425
Completed
Not Applicable

A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery

Vanderbilt University Medical Center1 site in 1 country190 target enrollmentJune 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Vanderbilt University Medical Center
Enrollment
190
Locations
1
Primary Endpoint
Unused Opioids
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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. Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.

Detailed Description

Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (\~25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.

Registry
clinicaltrials.gov
Start Date
June 14, 2017
End Date
September 21, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Osmundson

Assistant Professor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Women 18-50 years old
  • Women undergoing cesarean delivery at a single institution

Exclusion Criteria

  • Major post-surgical complications: cesarean hysterectomy, bowl 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.
  • Non English or Spanish speaking

Outcomes

Primary Outcomes

Unused Opioids

Time Frame: 4 weeks postpartum

oxycodone 5mg tablet leftover from prescription at discharge

Secondary Outcomes

  • Pain: Frequency That Participants Reported Uncontrolled Pain(4 weeks postpartum)

Study Sites (1)

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