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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

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE November 1, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03355248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
Post-cesarean patient satisfaction with management [ Time Frame: 1 week post-op cesarean ]
Secondary outcomes include patient satisfaction as assessed by a survey
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Satisfaction Following Cesarean Section
Official Title  ICMJE The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Pain, Postoperative
  • Cesarean Section Complications
  • Postpartum Disorder
  • Opioid Use
Intervention  ICMJE Other: Oxycodone Acetaminophen
Decrease in opioid prescribing for post-operative cesarean pain management
Other Name: Percocet
Study Arms  ICMJE
  • 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
    Intervention: Other: Oxycodone Acetaminophen
  • 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
    Intervention: Other: Oxycodone Acetaminophen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Postpartum cesarean patients
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Danielle Beaver, M.D. 317-750-9677 danielle.beaver@utoledo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355248
Other Study ID Numbers  ICMJE IRB #17-064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party James Van Hook, ProMedica Health System
Study Sponsor  ICMJE ProMedica Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Van Hook, MD ProMedica Health System
PRS Account ProMedica Health System
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP