NCT03168425

Opioid Prescribing After Cesarean Delivery

Completed NA Results posted Last updated 3 June 2019

What this trial tests

NA trial testing Tailored prescription in Surgery in 190 participants. Completed in 21 September 2017.

Timeline

14 June 2017

Primary endpoint
21 September 2017

21 September 2017

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	190
Start date	14 June 2017
Primary completion	21 September 2017
Estimated completion	21 September 2017
Sites	1 location across United States

Drugs / interventions tested

• Tailored prescription
• Control

Conditions studied

• Surgery — all drugs for Surgery →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Vanderbilt University Medical Center

Who can join

Adults 18 to 50, female only, with Surgery or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Unused Opioids Primary · 4 weeks postpartum

oxycodone 5mg tablet leftover from prescription at discharge

Group	Value	95% CI
Tailored	5	1 – 8
Control	10	0 – 22

Pain: Frequency That Participants Reported Uncontrolled Pain Secondary · 4 weeks postpartum

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 (Y

Group	Value	95% CI
Tailored	4	2 – 5
Control	3	2 – 5

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tailored

Serious: 1/94 (1%)

Deaths: 0/94

Control

Serious: 0/96 (0%)

Deaths: 0/96

Serious adverse events (1 terms)

Reaction	System	Tailored	Control
Surgical Site Infection	Pregnancy, puerperium and perinatal conditions	—	—

Most-reported serious reactions: Surgical Site Infection.

Data from ClinicalTrials.gov NCT03168425 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial.
   Osmundson SS, Raymond BL, Kook BT, Lam L, et al · · 2018 · cited 43× · PMID 30095773 · DOI 10.1097/aog.0000000000002782