Satisfaction Following Cesarean Section
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ClinicalTrials.gov Identifier: NCT03355248 |
Recruitment Status :
Completed
First Posted : November 28, 2017
Last Update Posted : September 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative Cesarean Section Complications Postpartum Disorder Opioid Use | Other: Oxycodone Acetaminophen | Not Applicable |
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:
- Age
- Race
- Insurance
- Repeat cesarean section
- Classification of cesarean section (scheduled, unscheduled, emergent)
- Type of skin incision and closure
- Urine toxicology screen results
- Tubal ligation at the time of cesarean
- Anesthesia (General or regional [epidural, spinal or combined], if regional, duramorph given)
- Length of hospital stay
- Number of refills
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Participant) |
Masking Description: | Participants are blinded to the group assignment and are not made aware of what interventions are being assigned, only that pain management and satisfaction are being evaluated |
Primary Purpose: | Health Services Research |
Official Title: | The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section |
Actual Study Start Date : | August 18, 2017 |
Actual Primary Completion Date : | August 14, 2020 |
Actual Study Completion Date : | August 14, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Control Group - 28
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
|
Other: Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
Other Name: Percocet |
Experimental: Experimental - 20
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
|
Other: Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
Other Name: Percocet |
- Post-cesarean pain management [ Time Frame: 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.
- Post-cesarean patient satisfaction with management [ Time Frame: 1 week post-op cesarean ]Secondary outcomes include patient satisfaction as assessed by a survey

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Postpartum cesarean patients |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Center for health services (CHS) patient
- Cesarean section
- >/= 18 years of age
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355248
United States, Ohio | |
Center for Health Services | |
Toledo, Ohio, United States, 43606 |
Principal Investigator: | James Van Hook, MD | ProMedica Health System |
Responsible Party: | James Van Hook, Medical Doctor, ProMedica Health System |
ClinicalTrials.gov Identifier: | NCT03355248 |
Other Study ID Numbers: |
IRB #17-064 |
First Posted: | November 28, 2017 Key Record Dates |
Last Update Posted: | September 18, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
postpartum postoperative cesarean pain management opioid requirements |
Puerperal Disorders Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Pregnancy Complications Acetaminophen Acetaminophen, hydrocodone drug combination Oxycodone Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |