跳至主要内容
临床试验/NCT06114121
NCT06114121暂停4 期

Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain

University of Miami0 个研究点目标入组 100 人开始时间: 2024年7月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
暂停
入组人数
100
主要终点
post-operative opioid analgesic medication

研究概览

简要总结

The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Adults unable to consent
  • Individuals <18 years of age at time of admission
  • Individuals taking anticoagulant medications
  • Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation)
  • Pre-existing chronic pain or pain disorder diagnosis
  • Conversion from neuraxial to general anesthesia
  • Prisoners

研究组 & 干预措施

erector spinae plane block

Experimental

participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block

干预措施: erector spinae plane block (ESP) (Procedure)

erector spinae plane block

Experimental

participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block

干预措施: Duramorph (Drug)

erector spinae plane block

Experimental

participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block

干预措施: Ropivacaine (Drug)

erector spinae plane block

Experimental

participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block

干预措施: Bupivacaine Injection (Drug)

standard of care

Experimental

participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.

干预措施: Duramorph (Drug)

standard of care

Experimental

participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.

干预措施: Ropivacaine (Drug)

standard of care

Experimental

participants in this group will receive the standard of care treatment and will be in this group for up to 9 months.

干预措施: Bupivacaine Injection (Drug)

结局指标

主要结局

post-operative opioid analgesic medication

时间窗: up to 24 hours

measurement (milligrams)

次要结局

  • change in post-operative pain medication by visual analog scale(baseline, up to 24 hours)
  • number of minutes to first use of rescue medication(up to 24 hours)
  • obstetric quality of recovery scale(up to 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Reine Zbeidy

Associate Professor of Clinical Anesthesiology

University of Miami

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