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NCT03355248 · ClinicalTrials.gov registry record · NA
Satisfaction Following Cesarean Section
A NA study, sponsored by ProMedica Health System.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT03355248: Completed NA study, sponsored by ProMedica Health System.
NCT03355248 is a NA study that has completed, run by ProMedica Health System. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355248, a NA study, has completed, sponsored by ProMedica Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
Presently, the standard of care at the investigators' practice is that the discharging physician decides the type and amount of opioid medication to prescribe a patient following a cesarean section. After informed consent has been obtained, patients will be enrolled in this randomized-controlled equivalence study. The experimental group will be prescribed 20 oxycodone-acetaminophen and the control group will be prescribed 28 oxycodone-acetaminophen at the time of discharge. Both groups will also be provided with a handout on non-opioid analgesia. The groups will be assigned randomly in blocks. The investigators will recruit patients either in the clinic, if participants are to have a scheduled cesarean section, or at some time during the hospital admission for delivery. The satisfaction survey and pain scale will be administered at the postoperative check by the clinic staff and providers. These surveys will be stored in a secure location at the clinic. If the patient does not show up for their postoperative visit, 3 attempts total will be made by an investigator to reach the patient and administer both surveys by phone within 2 weeks of discharge. A preliminary analysis of the data will be done once half the study patients have been recruited. The investigators do not foresee any threats to the external or internal validity of the study. The investigators are taking many measures to limit study bias. First, block randomization will help limit discrepancies between groups. Also, strict adherence to the inclusion and exclusion criteria will also help limit confounders that may make data difficult to interpret, such as non-opioid naïve patients and complications that may potentially increase pain and opioid requirements. Lastly, blinding of patients to the number of pills participants receive will help mitigate patient bias.
Primary Outcome
Our main aim is to determine the effect of decreased opioid prescribing on pain control following cesarean section. Our hypothesis is that despite decreased opioid prescribing \[20 oxycodone-acetaminophen (5/325mg)\] following cesarean section, pain scores will be equivalent to the control group \[28 oxycodone-acetaminophen (5/325mg)\]. Pain control will be measured by an 11-point numeric scale.
Interventions
- OTHER Oxycodone Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-08-18 |
| Est. Completion | 2020-08-14 |
| Phase | NA |
What the finished NCT03355248 record still lists
NCT03355248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxycodone Acetaminophen is the first listed.
NCT03355248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03355248 about?
NCT03355248 is a clinical study titled "Satisfaction Following Cesarean Section". Presently, the standard of care at the investigators' practice is that the discharging physician decides the type and amount of opioid medication to prescribe a patient following a cesarean section. After informed consent has been obtained, patients will be enrolled in this randomized-controlled equ...
What is the current status of trial NCT03355248?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-08-18. Estimated completion is 2020-08-14.
What interventions are being tested in trial NCT03355248?
The interventions under investigation include: Oxycodone Acetaminophen (OTHER).
Who is sponsoring clinical trial NCT03355248?
This trial is sponsored by ProMedica Health System, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03355248's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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