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Satisfaction Following Cesarean Section

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ClinicalTrials.gov Identifier: NCT03355248
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
James Van Hook, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Cesarean Section Complications Postpartum Disorder Opioid Use Other: Oxycodone Acetaminophen Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Post-cesarean patient satisfaction with management [ Time Frame: 1 week post-op cesarean ]
    Secondary outcomes include patient satisfaction as assessed by a survey



Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Danielle Beaver, M.D. 317-750-9677 danielle.beaver@utoledo.edu

Locations
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United States, Ohio
Center for Health Services Recruiting
Toledo, Ohio, United States, 43606
Contact: Mate M Soric, PharmD    419-291-1873    mate.soric@promedica.org   
Sponsors and Collaborators
ProMedica Health System
Investigators
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Principal Investigator: James Van Hook, MD ProMedica Health System

Publications:
Centers for Disease Control and Prevention. Wide-ranging Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-Death file, 2000-2014. 2015. Available at: http://www.cdc.gov/nchs/data/health_ policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf. Accessed June 9, 2017.

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Responsible Party: James Van Hook, Medical Doctor, ProMedica Health System
ClinicalTrials.gov Identifier: NCT03355248     History of Changes
Other Study ID Numbers: IRB #17-064
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Van Hook, ProMedica Health System:
postpartum
postoperative cesarean pain management
opioid requirements

Additional relevant MeSH terms:
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Pain, Postoperative
Puerperal Disorders
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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