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Clinical Trials/NCT03959969
NCT03959969
Completed
Not Applicable

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

Medstar Health Research Institute1 site in 1 country48 target enrollmentJuly 17, 2019

Overview

Phase
Not Applicable
Intervention
Educational video
Conditions
Opioid Use, Unspecified
Sponsor
Medstar Health Research Institute
Enrollment
48
Locations
1
Primary Endpoint
Number of oxycodone tablets used fourteen days after cesarean delivery
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2019
End Date
January 11, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Medstar Health Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Sara N. Iqbal

Maternal Fetal Medicine Fellowship Program Director

Medstar Health Research Institute

Eligibility 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

Arms & Interventions

Educational Video Recipients

Participants will be shown educational video on pain management after cesarean delivery on day of discharge. 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.

Intervention: Educational video

Educational Video Recipients

Participants will be shown educational video on pain management after cesarean delivery on day of discharge. 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.

Intervention: Ibuprofen

Educational Video Recipients

Participants will be shown educational video on pain management after cesarean delivery on day of discharge. 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.

Intervention: Oxycodone

Standard of Care Recipients

Participants will be given standard of care discharge instructions for pain management on day of discharge. 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.

Intervention: Standard of care

Standard of Care Recipients

Participants will be given standard of care discharge instructions for pain management on day of discharge. 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.

Intervention: Ibuprofen

Standard of Care Recipients

Participants will be given standard of care discharge instructions for pain management on day of discharge. 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.

Intervention: Oxycodone

Outcomes

Primary Outcomes

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 Outcomes

  • Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery(7 days after cesarean delivery (postpartum day number 7))
  • Adjunct medication use at seven days after cesarean delivery(7 days after cesarean delivery (postpartum day number 7))
  • Overall pain management satisfaction using Likert scale seven days after cesarean delivery(7 days after cesarean delivery (postpartum day number 7))
  • Adjunct medication use at fourteen days after cesarean delivery(14 days after cesarean delivery (postpartum day number 14))
  • Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery(14 days after cesarean delivery (postpartum day number 14))
  • Number of oxycodone tablets used seven days after cesarean delivery(7 days after cesarean delivery (postpartum day number 7))
  • Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery(14 days after cesarean delivery (postpartum day number 14))
  • Total number of oxycodone tablets used inpatient(3 days)

Study Sites (1)

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