Opioid Prescribing After Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery, Opioid Use

Intervention / Treatment
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* Other: Tailored prescription
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored<br>Participants will be prescribed an opioid based on a formula derived from inpatient opioid use | Other: Tailored prescription<br>* Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use<br>|
| Other: Control<br>Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. | Other: Control<br>* Participants will be prescribed 30 tablets of oxycodone 5mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unused Opioids | oxycodone 5mg tablet leftover from prescription at discharge | 4 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safe opioid prescribing