Opioid Use, Unspecified
Conditions
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.
Interventions
OTHEREducational 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.
OTHERStandard of care
The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.
DRUGIbuprofen
Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
DRUGOxycodone
Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oxycodone tablets used fourteen days after cesarean delivery | 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
| Measure | Time frame | Description |
|---|---|---|
| Adjunct medication use at seven days after cesarean delivery | 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. |
| Overall pain management satisfaction using Likert scale seven days after cesarean delivery | 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. |
| Pain assessment score from numeric pain intensity scale at fourteen days after cesarean delivery | 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. |
| Pain assessment score from numeric pain intensity scale at seven days after cesarean delivery | 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. |
| Overall pain management satisfaction using Likert scale fourteen days after cesarean delivery | 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. |
| Total number of oxycodone tablets used inpatient | 3 days | Total oxycodone tablets used during patient's inpatient stay after cesarean delivery. |
| Number of oxycodone tablets used seven days after cesarean delivery | 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). |
| Adjunct medication use at fourteen days after cesarean delivery | 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. |
Countries
United States
Outcome results
None listed