SurgeryNCT03168425
Opioid Prescribing After Cesarean Delivery
A study testing Tailored prescription in people with Surgery and Opioid Use, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery, Opioid Use
- What is being tested?
- Tailored prescription
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2017to 21 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18-50 years old
- Women undergoing cesarean delivery at a single institution
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery
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.
Read the detailed description
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (~25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
- Conditions
- Surgery, Opioid Use
- Being tested
- Tailored prescription, Control
- Keywords
- safe opioid prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Tailored | Experimental | Participants will be prescribed an opioid based on a formula derived from inpatient opioid use Receives: Other: Tailored prescription |
| Control | Other | Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unused Opioids
oxycodone 5mg tablet leftover from prescription at discharge
Measured: 4 weeks postpartum
Secondary outcomes (1)
Pain: Frequency That Participants Reported Uncontrolled Pain
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 (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0)
Measured: 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start14 Jun 2017
- Primary completion21 Sep 2017
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Osmundson, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168425
- Sponsor's protocol ID
- OSMUNDSS04192017181235
- Status last verified
- Feb 2019
- First submitted
- 22 May 2017
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30095773
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03168425
- Acronym / sponsor ID
- OSMUNDSS04192017181235
- Conditions
- Surgery, Opioid Use
- Keywords
- safe opioid prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (~25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
| Arm | Type | Receives |
|---|---|---|
| Tailored | Experimental | Other: Tailored prescriptionParticipants will be prescribed an opioid based on a formula derived from inpatient opioid use |
| Control | Other | Other: ControlParticipants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women 18-50 years old
- Women undergoing cesarean delivery at a single institution
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored prescriptionParticipants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use | Other | Tailored |
| ControlParticipants will be prescribed 30 tablets of oxycodone 5mg | Other | Control |
Primary outcome
Unused Opioids
Time frame: 4 weeks postpartum
oxycodone 5mg tablet leftover from prescription at discharge
1 secondary outcome
Pain: Frequency That Participants Reported Uncontrolled Pain
Time frame: 4 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30095773Osmundson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored prescription in people with Surgery and Opioid Use, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unused Opioids (time frame: 4 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03168425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019; AzTrials last refreshed its copy on 29 Oct 2026.