Clinical trial NCT03168425: Opioid Prescribing After Cesarean Delivery
Official title: A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Opioid Use
Keywords: safe opioid prescribing
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Unused Opioids
timeFrame: 4 weeks postpartum
Secondary outcomes:
measure: Pain: Frequency That Participants Reported Uncontrolled Pain
timeFrame: 4 weeks postpartum
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Osmundson
state: Tennessee
Study officials:
References:
citation: Osmundson SS, Raymond BL, Kook BT, Lam L, Thompson EB, Schornack LA, Voorhees CE, Richardson MG. Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):624-630. doi: 10.1097/AOG.0000000000002782.