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Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03959969
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sara N. Iqbal, Medstar Health Research Institute

Brief Summary:
This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.

Condition or disease Intervention/treatment Phase
Opioid Use, Unspecified Other: Educational video Other: Standard of care Drug: Ibuprofen Drug: Oxycodone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does an Educational Video During the Postpartum Period Reduce the Rates of Opioid Use After Cesarean Section? A Randomized Controlled Trial
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Educational Video Recipients
Participants will be shown educational video on pain management after cesarean delivery on postpartum day number 2. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.
Other: Educational video
An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.

Drug: Ibuprofen
Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
Other Name: Advil

Drug: Oxycodone
Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.

Active Comparator: Standard of Care Recipients
Participants will be given standard of care discharge instructions for pain management on postpartum day number 3, when discharged. Upon discharge, participants will be given twenty tablets of oxycodone 5 mg by mouth every four hours as needed for pain and forty tablets of ibuprofen 600 mg by mouth every six hours as needed for pain.
Other: Standard of care
The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.

Drug: Ibuprofen
Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
Other Name: Advil

Drug: Oxycodone
Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.




Primary Outcome Measures :
  1. Number of oxycodone tablets used seven days after cesarean delivery [ Time Frame: 7 days after cesarean delivery (postpartum day number 7) ]
    This is the total number of oxycodone tablets used by participants in each arm seven days after cesarean delivery (postpartum day number 7).

  2. Number of oxycodone tablets used fourteen days after cesarean delivery [ Time Frame: A total of 14 days after cesarean delivery (postpartum day number 14) ]
    This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14).


Secondary Outcome Measures :
  1. Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery [ Time Frame: 7 days after cesarean delivery (postpartum day number 7) ]
    Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score seven days after cesarean delivery (postpartum day 7). The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.

  2. Adjunct medication use at seven days after cesarean delivery [ Time Frame: 7 days after cesarean delivery (postpartum day number 7) ]
    This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, seven days after cesarean delivery.

  3. Overall pain management satisfaction using Likert scale seven days after cesarean delivery [ Time Frame: 7 days after cesarean delivery (postpartum day number 7) ]
    Assessment of overall pain management satisfaction seven days after cesarean delivery (postpartum day number 7) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.

  4. Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery [ Time Frame: 14 days after cesarean delivery (postpartum day number 14) ]
    Using an universal pain assessment tool of a numeric pain intensity scale, patients will be asked their pain score fourteen days after cesarean delivery (postpartum day 14).The numeric pain intensity scale is 0-10, with 0 being no pain and 10 being the worst pain possible.

  5. Adjunct medication use at fourteen days after cesarean delivery [ Time Frame: 14 days after cesarean delivery (postpartum day number 14) ]
    This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, fourteen days after cesarean delivery.

  6. Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery [ Time Frame: 14 days after cesarean delivery (postpartum day number 14) ]
    Assessment of overall pain management satisfaction fourteen days after cesarean delivery (postpartum day number 14) with five point Likert scale. The Likert scale ranges from extremely satisfied with pain management to extremely dissatisfied with pain management.

  7. Total number of oxycodone tablets used inpatient [ Time Frame: 3 days ]
    Total oxycodone tablets used during patient's inpatient stay after cesarean delivery.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Greater than 18 years of age
  • Underwent repeat or primary C-section
  • Literate in English Language

Exclusion Criteria:

  • Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back
  • History of opioid use disorder and/or on chronic opiates in pregnancy
  • Contraindications to NSAIDS or acetaminophen

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): NCT03959969


Contacts
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Contact: Neggin Mokhtari, MD 202-877-3067 neggin.mokhtari@medstar.net

Sponsors and Collaborators
Medstar Health Research Institute
Investigators
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Principal Investigator: Sara Iqbal, MD Medstar Washington Hospital Center

Publications:
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Responsible Party: Sara N. Iqbal, Maternal Fetal Medicine Fellowship Program Director, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT03959969     History of Changes
Other Study ID Numbers: STUDY00000260
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Ibuprofen
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants