Satisfaction Following Cesarean Section

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Opioid Use; Pain, Postoperative; Postpartum Disorder
• Interventions: Other: Oxycodone Acetaminophen

• Registration Number: NCT03355248
• Lead Sponsor: ProMedica Health System

Brief 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.

Detailed Description

Presently, the standard of care at our 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 our randomized-control, 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. 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. First, block randomization will help limit discrepancies between groups.

Subject evaluation will generally be limited to no more than 3 weeks following surgery. Evaluations will occur at the postoperative visit via two surveys (see below). If the patient does not show up for the clinic visit, 3 attempts will be made by an investigator to reach the patient and administer both surveys by phone within 2 weeks of discharge.

Variables of interest:

1. Age

2. Race

3. Insurance

4. Repeat cesarean section

5. Classification of cesarean section (scheduled, unscheduled, emergent)

6. Type of skin incision and closure

7. Urine toxicology screen results

8. Tubal ligation at the time of cesarean

9. Anesthesia (General or regional \[epidural, spinal or combined\], if regional, duramorph given)

10. Length of hospital stay

11. Number of refills

Study Timeline

• Study Start: 2017-08-18
• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-28
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Center for health services (CHS) patient
2. Cesarean section
3. >/= 18 years of age

Exclusion Criteria

1. Non-CHS patients (i.e. regional or private)
2. <18 years of age
3. Allergy to hydrocodone, oxycodone, acetaminophen or NSAIDs
4. Contraindication to using medications (i.e hypertensive disorders of pregnancy)
5. Hospitalization >7 days, which suggest complications that may increase pain and opioid requirements
6. Complications (wound infections, re-explorations, cesarean hysterectomies, etc...)
7. Urine toxicology screen positive for opioids on admission
8. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control Group - 28	Oxycodone Acetaminophen	The control group (post-operative cesarean section) 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. Specifically, the first half of the patients will automatically be placed in the experimental arm and the second half into the control arm of the study
Experimental - 20	Oxycodone Acetaminophen	The experimental group (post-operative cesarean section) will be prescribed 20 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. Specifically, the first half of the patients will automatically be placed in the experimental arm and the second half into the control arm of the study

Primary Outcome Measures

Name	Time	Method
Post-cesarean pain management	1 week post-op cesarean	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.

Secondary Outcome Measures

Name	Time	Method
Post-cesarean patient satisfaction with management	1 week post-op cesarean	Secondary outcomes include patient satisfaction as assessed by a survey

Trial Locations

Locations (1)

Center for Health Services; 🇺🇸 Toledo, Ohio, United States