Satisfaction Following Cesarean Section

Completed · Not applicable

Conditions studied: Pain, Postoperative, Cesarean Section Complications, Postpartum Disorder, Opioid Use

In brief

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.

Key facts

Study ID

NCT03355248

Run by

ProMedica Health System

People needed

60

Starts

2017-08-18

Expected to finish

2020-08-14

Last updated by the study team

2020-09-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Center for health services (CHS) patient
• Cesarean section
• >/= 18 years of age

You may not qualify if…

• Non-CHS patients (i.e. regional or private)
• <18 years of age
• Allergy to hydrocodone, oxycodone, acetaminophen or NSAIDs
• Contraindication to using medications (i.e hypertensive disorders of pregnancy)
• Hospitalization >7 days, which suggest complications that may increase pain and opioid requirements
• Complications (wound infections, re-explorations, cesarean hysterectomies, etc…)
• Urine toxicology screen positive for opioids on admission
• Recent use as defined by either patient reported use of opioids within the last 30 days or an Ohio Automated Rx Reporting System (OARRS) reports that shows prescription of opioids within 30 days of admission for delivery

Where it is running

• Center for Health Services — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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