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

Study Overview
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Brief Summary
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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.

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

Conditions
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Opioid Use, Unspecified

Intervention / Treatment
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* Other: Educational video
* Other: Standard of care
* Drug: Ibuprofen
* Drug: Oxycodone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Video Recipients<br>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. | Other: Educational video<br>* 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.<br>Drug: Ibuprofen<br>* Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.<br>* Other names: Advil;Drug: Oxycodone<br>* Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.<br>|
| Active Comparator: Standard of Care Recipients<br>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. | Other: Standard of care<br>* The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.<br>Drug: Ibuprofen<br>* Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.<br>* Other names: Advil;Drug: Oxycodone<br>* Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oxycodone tablets used fourteen days after cesarean delivery | This is the total number of oxycodone tablets used by participants in each arm fourteen days after cesarean delivery (postpartum day number 14). | A total of 14 days after cesarean delivery (postpartum day number 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery | 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. | 7 days after cesarean delivery (postpartum day number 7) | 
| Adjunct medication use at seven days after cesarean delivery | This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, 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 | 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. | 7 days after cesarean delivery (postpartum day number 7) | 
| Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery | 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. | 14 days after cesarean delivery (postpartum day number 14) | 
| Adjunct medication use at fourteen days after cesarean delivery | This is to determine use of adjunct medications such as ibuprofen and Tylenol in the participants in both arms, 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 | 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. | 14 days after cesarean delivery (postpartum day number 14) | 
| Total number of oxycodone tablets used inpatient | Total oxycodone tablets used during patient's inpatient stay after cesarean delivery. | 3 days | 
| Number of oxycodone tablets used seven days after cesarean delivery | This is the total number of oxycodone tablets used by participants in each arm seven days after cesarean delivery (postpartum day number 7). | 7 days after cesarean delivery (postpartum day number 7) |