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OpenTrials
Completed

NCT Number: NCT03168425

Opioid Prescribing After Cesarean Delivery

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.

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Key information

Conditions

Surgery Opioid Use

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sarah Osmundson

Nashville, Tennessee, 37215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored prescription

Other

Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use

Control

Other

Participants will be prescribed 30 tablets of oxycodone 5mg

Primary outcomes

  1. Unused Opioids

    Time frame: 4 weeks postpartum

    oxycodone 5mg tablet leftover from prescription at discharge

Secondary outcomes

  1. Pain: Frequency That Participants Reported Uncontrolled Pain

    Time frame: 4 weeks postpartum

    Frequency that participants reported uncontrolled pain

    Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5.

    Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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