Opioid Prescribing After Cesarean Delivery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168425
• Other study ID #: OSMUNDSS04192017181235
• Status: Completed
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: September 21, 2017

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: September 21, 2017
• Est. primary completion date: September 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Surgery

Intervention

Other:
• Tailored prescription
Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
• Control
Participants will be prescribed 30 tablets of oxycodone 5mg

Locations

Country	Name	City	State
United States	Sarah Osmundson	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unused Opioids	oxycodone 5mg tablet leftover from prescription at discharge	4 weeks postpartum
Secondary	Pain: Frequency That Participants Reported Uncontrolled Pain	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)	4 weeks postpartum