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Completed

NCT Number: NCT03959969

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

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.

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Key information

Conditions

Opioid Use, Unspecified

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Video

Other

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.

Standard of care

Other

The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.

Ibuprofen

Drug

Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.

Other names: Advil

Oxycodone

Drug

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

Primary outcomes

  1. 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

  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.

  8. 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).

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 22, 2019
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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