Discharge Opioid Education to Decrease Opioid Use After Cesarean
Phase: NA
Conditions: Opioid Use
Sponsor: Vanderbilt University Medical Center

Discharge opioid education to decrease opioid use after cesarean: a
randomized controlled trial
July 2, 2018
NCT03678870 

Discharge opioid education to decrease opioid use after cesarean: a 
randomized controlled trial 
Page 1 of 3 
Version Date: July 2, 2018 
1.0 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.   
2.0 Objective: To compare discharge opioid education to standard care to ascertain 
whether opioid education reduces opioid use after hospital discharge 
3.0 Preliminary Data: Our previously published study (Osmundson, 2018) 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. 
4.0 Eligibility 
Ø Inclusion Criteria
•
Women 18-45 years old
•
Women undergoing cesarean delivery at VUMC
Ø Exclusion Criteria
1. Major post-surgical complications:
o
cesarean hysterectomy, bowl or bladder injury, reoperation, ICU
admission, wound infection or separation
2. Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for
> 7 days during pregnancy.
3. Women who do not speak English
5.0 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 sealedenvelope.com
•
Randomization and allocation will be done through RedCap

Discharge opioid education to decrease opioid use after cesarean: a 
randomized controlled trial 
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6.0 Study Procedures 
1. Enrollment
2. Postoperative Day 0-1: Survey 1 through RedCap (takes ~10 minutes)
3. Randomization education versus usual care
a. Control = Standard discharge instructions, which list medications prescribed at
discharge
b. Intervention = a single page handout (see attachment) with information about
how to use medications for pain after discharge. This handout contains the
following instructions
o
Get baseline pain control with ibuprofen
o
Use your opioid prescription only if your pain is very bad
o
Taper your medications
o
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
o
Ibuprofen 600mg: 30 tablets
o
Hydrocodone 5mg -acetaminophen 325mg: 30 tablets
5. Postoperative day 14: All participants will be contacted to complete Survey 2 (Takes
~ 15 minutes
o
Attempts to contact each participant will be done 3 times before they are
designated as “lost to follow up”
o
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 5mg -acetaminophen 325mg used after 
hospital discharge 
Secondary Outcomes: 
•
Frequency of disposing opioids correctly
•
Median score on the analgesic assessment
7.0 Risks 
o
Breach of confidentiality of protected health information
8.0 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. 
9.0 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.  

Discharge opioid education to decrease opioid use after cesarean: a 
randomized controlled trial 
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10.0 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.  
11.0 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.