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临床试验/NCT06012747
NCT06012747已完成不适用

Pain After Cesarean Section - A Danish Multicenter Cohort Study.

Nordsjaellands Hospital19 个研究点 分布在 1 个国家目标入组 752 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
752
试验地点
19
主要终点
Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10

研究概览

简要总结

Pain after a cesarean section is of moderate to severe intensity. A Danish multicenter study from 2021 used an obstetric Quality of Recovery score 24 hours after the cesarean section and found that 45% of 861 patients had experienced very severe pain during recovery.

This result was surprisingly high but also unspecific. Therefore, the investigators aim to investigate the intensity of pain experienced by patients at specific time intervals after the cesarean section e.g., every 6th hour. Additionally, the investigators will examine whether the pain has an impact on important functions for both the patients and the newborns, as well as assess the overall morphine consumption.

All Danish regions have approved the REDCap database as a secure way to collect and store data. REDCap can also send encrypted links that can be converted into SMS messages sent to the participants' mobile phones at fixed intervals, allowing participants to enter data directly into the secure system. The investigators also aim to feasibility test the system.

When a child is delivered by cesarean section, it is an expectation that the mother can take care of herself and the baby a few hours after the surgery. However, severe pain can hinder this. Therefore, it is important to investigate whether pain relief for our patients is sufficient.

Based on response rates and the frequency of outcomes, data from this observational study can support the design of a future national multicenter randomized controlled trial (RCT) with a focus on postoperative pain intervention. The incidences of binary outcome measures and standard deviations of continuous outcome measures will support the sample size calculations for our RCT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • Age < 18 years

结局指标

主要结局

Self reported pain on movement from supine position to sitting position after 24 hours, NRS 0-10

时间窗: 24 hours after cesarean section

Patient reported

Neonatal admission ,

时间窗: within 24 hours

yes/no

Composite outcome of self reported morphine side effects occurring within 24 hours For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.

时间窗: 24 hours after cesarean section

consisting of either nausea, dizziness, itching, vomiting, or urinary retention. Nausea, itching, and dizziness are recorded on a 4-point scale: None, mild, moderate, severe. Where moderate and severe are considered side effects. For vomiting and urinary retention, this is recorded as yes/no, where yes is considered a side effect.

次要结局

  • See protokol for the multible secondary and exploratory outcomes(0-30 days)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Duch

MD Patricia Duch

Nordsjaellands Hospital

研究点 (19)

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