Opioid Prescribing After Cesarean Delivery

Vanderbilt University Medical Center

Status: Completed

Conditions: Surgery; Opioid Use

Treatments: Other: Control; Other: Tailored prescription

Study type: Interventional

Funder types: Other

Identifiers

NCT03168425

OSMUNDSS04192017181235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Tailored

Experimental group

Description:

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

Treatment:

Other: Tailored prescription

Control

Other group

Description:

Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.

Treatment:

Other: Control