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临床试验/NCT03959969
NCT03959969已完成不适用

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

Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Number of oxycodone tablets used fourteen days after cesarean delivery

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Educational Video Recipients

Experimental

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.

干预措施: Educational video (Other)

Educational Video Recipients

Experimental

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.

干预措施: Ibuprofen (Drug)

Educational Video Recipients

Experimental

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.

干预措施: Oxycodone (Drug)

Standard of Care Recipients

Active Comparator

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.

干预措施: Standard of care (Other)

Standard of Care Recipients

Active Comparator

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.

干预措施: Ibuprofen (Drug)

Standard of Care Recipients

Active Comparator

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.

干预措施: Oxycodone (Drug)

结局指标

主要结局

Number of oxycodone tablets used fourteen days after cesarean delivery

时间窗: 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).

次要结局

  • 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)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara N. Iqbal

Maternal Fetal Medicine Fellowship Program Director

Medstar Health Research Institute

研究点 (1)

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