Discharge Opioid Education to Decrease Opioid Use After Cesarean

Background: 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 and higher
opioid use after surgery has been associated with an increased risk of chronic opioid use.
Reducing the amount of opioid used after cesarean delivery may decrease the risk of chronic
opioid use and will help towards better estimating and reducing the amount of opioids
prescribed at discharge.

Objective: To to compare discharge opioid education to standard care to ascertain whether
opioid education reduces opioid use after hospital discharge

Preliminary Data: Our soon to be published study (Obstetrics & Gynecology Journal) found that
30% of women used all their opioids after discharge for cesarean delivery because they "were
following directions" and not because they had pain.

Enrollment & Randomization

Enrollment

- Participants will be approached after their cesarean delivery either in the recovery
room or in their private postpartum room

- Informed written consent will be obtained by a trained research assistant (i.e. medical
student) or by the study researchers (Attendings, fellows)

- After enrollment, participants will be asked to complete Survey 1 either in person or by
giving sending them the web link with RedCap

Randomization

- Enrolled patients will be randomized in a 1:1 ratio using permuted blocks of 6

- Randomization sequence will be developed through sealed envelope.com

- Randomization and allocation will be done through RedCap

Study Procedures

1. Enrollment

2. Postoperative Day 0-1: Survey 1 through RedCap (takes ~10 minutes)

3. Randomization education versus usual care

1. Control = Standard discharge instructions, which list medications prescribed at
discharge

2. Intervention = a single page handout (see attachment) with information about how to
use medications for pain after discharge. This handout contains the following
instructions

- Get baseline pain control with ibuprofen

- Use your opioid prescription only if your pain is very bad

- Taper your medications

- Get rid of leftover opioid tablets

4. At discharge all patients will receive the follow medications using PillsyCaps. These
are standard medications given at discharge at our institution

- Ibuprofen 600mg: 30 tablets

- Hydrocodone 5mg -acetaminophen 325mg: 30 tablets

5. Postoperative day 14: All participants will be contacted to complete Survey 2 (Takes ~
15 minutes

- Attempts to contact each participant will be done 3 times before they are
designated as "lost to follow up"

- If a participant is still using opioids on postoperative day 14, they should be
contacted weekly until they are no longer taking opioids

Primary Outcome Median number of tablets of hydrocodone-acetaminophen used after hospital
discharge

Secondary Outcomes:

- VAS pain score (median)

- Percentage of patients reporting pain since discharge as worse than expected

- Percentage of patients obtaining additional prescriptions for pain

- Percentage of patients with unscheduled visits for pain

- Mean ibuprofen milligrams used hours 24-47 after cesarean

- Mean acetaminophen milligrams used hours 24-47 after cesarean

- Total MME used per hour of inpatient stay

Risks

o Breach of confidentiality of protected health information

Reporting Adverse Events Any adverse events or unanticipated problems involving risk to
participants or others will be reported to the IRB and the VUMC privacy office within 7 days
of discovery.

Study Withdrawal/discontinuation Participants may withdraw at any time by providing written
intent to the Primary Investigator. Participants may be removed from the study if they
develop a major surgical complication after their cesarean.

Statistical Considerations

Using prior data, the average opioid MME used per person was 130 MME (SD 90) in the "average
use" group. With an alpha of 5% and a beta of 80%, we estimate that 160 total participants
are required to show a 30% reduction in opioid used. Assuming a lost to follow up rate of
20%, we plan to enroll 200 women.

Follow-up and Record Retention On average 100 cesareans are performed per month. With a 50%
enrollment rate, we anticipate this study will take 4 months to complete

The patient list will be destroyed upon data analysis and publication. Redcap will be
archived upon publication.

Inclusion Criteria:

- Women 18-45 years old

- Women undergoing cesarean delivery at VUM

Exclusion Criteria:

- Major post-surgical complications:

- cesarean hysterectomy, bowel 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.

- Women who do not speak English