CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 190 enrolled
Drug / intervention
Tailored prescription +1 moreother
Likely dose
Oxycodone 5 mg tablets; tailored number based on inpatient opioid use vs. standard 30 tabletsAI-extracted
Key inclusion· 2
  • Women aged 18-50 years
  • Undergoing cesarean delivery at the study institution
Key exclusion· 3
  • Major post-surgical complications including cesarean hysterectomy, bowel or bladder injury, reoperation, ICU admission, or wound infection/separation
  • Chronic opioid use (buprenorphine during pregnancy or opioid use >7 days during pregnancy)
  • Non-English or non-Spanish speaking

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03168425
NCT03168425N/ACompleted

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

Vanderbilt University Medical Center·interventional·Posted May 30, 2017·Updated Jun 3, 2019

In Brief

A clinical study evaluating Tailored prescription and Control for Surgery and Opioid Use. Completed, enrolled 190 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery, Opioid Use
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 30, 2017
Enrollment StartJun 14, 2017
Primary CompletionSep 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.1 years ago

Interventions

Tailored prescriptionother

Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use

Controlother

Participants will be prescribed 30 tablets of oxycodone 5mg