CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Oxycodone Acetaminophenother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03355248
NCT03355248N/ACompleted

The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section

ProMedica Health System·interventional·Posted Nov 28, 2017·Updated Sep 18, 2020

In Brief

A clinical study evaluating Oxycodone Acetaminophen for Pain, Postoperative and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 28, 2017
Enrollment StartAug 18, 2017
Primary CompletionAug 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.6 years ago

Interventions

Oxycodone Acetaminophenother

Decrease in opioid prescribing for post-operative cesarean pain management