Opioid Prescribing After Cesarean Delivery

NCT03168425 | Completed Results

• 1 other identifier: OSMUNDSS04192017181235
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery; Opioid Use

Keywords

safe opioid prescribing

Outcome Measures

Primary Outcomes (1)

• Unused Opioids

  oxycodone 5mg tablet leftover from prescription at discharge

  4 weeks postpartum

Secondary Outcomes (1)

• Pain: Frequency That Participants Reported Uncontrolled Pain

  4 weeks postpartum

Study Arms (2)

Tailored

EXPERIMENTAL

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

Other: Tailored prescription

Control

OTHER

Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.

Other: Control

Interventions

Tailored prescription OTHER

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

Tailored

Control OTHER

Participants will be prescribed 30 tablets of oxycodone 5mg

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Postpartum women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-50 years old
• Women undergoing cesarean delivery at a single institution

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Sarah Osmundson

Nashville, Tennessee, 37215, United States

Location

Related Publications (1)

• Osmundson SS, Raymond BL, Kook BT, Lam L, Thompson EB, Schornack LA, Voorhees CE, Richardson MG. Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):624-630. doi: 10.1097/AOG.0000000000002782.

  PMID: 30095773 DERIVED

Results Point of Contact

• Title: Sarah Osmundson, MD
• Organization: Vanderbilt University Medical Center

sarah.osmundson@vumc.org

+1 (615) 343-5700

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: June 14, 2017
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)