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临床试验/CTRI/2024/02/063050
CTRI/2024/02/063050尚未招募不适用

Catheter Related Bladder Discomfort (CRBD) in oncological surgeries – incidence and impact of multimodal analgesia – a single center, prospective, observational study.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年2月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Observation of incidence of CRBD in the post operative period in oncological surgeries where multimodal analgesia is used.

研究概览

简要总结

Catheter related bladder discomfort (CRBD) is a significant but neglected event in the post anesthesia care unit (PACU). It is defined as the urgency to pass urine or pain/discomfort in the suprapubic region. Indwelling urinary catheters are used in various clinical situations however these urinary catheters can be quite distressing and can trigger serious behavioral reactions such as confusion and agitation and can also lead to traumatic attempts at removal of the catheter causing urethral injury and subsequent urinary stricture. This study aims at observing the incidence of CRBD in oncological surgeries where multimodal analgesia approach is used for pain management. This study will also study the severity of CRBD as well as the reduction in severity of CRBD after any kind of intervention. Currently the benefits of various analgesia approaches and other measures to relieve the pain and discomfort related to indwelling urinary catheters are still under evaluation. Results from this study will provide a further insight to our understanding and help us change pain management protocols if found beneficial

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients more than or equal to 18 years of age.
  • 2.Patients undergoing oncological surgeries under general anesthesia and needing urinary catheterization.

排除标准

  • 1.Patients unwilling to participate in the study.
  • 2.Patients catheterized prior to surgery.
  • 3.Multiple attempts at catheterization.
  • 4.Urogenital and pelvic surgeries.
  • 5.Surgeries with cognitive impairment in the post-operative period (neurosurgeries) 6.Patients shifted for elective ventilation (for more than 12 hrs.) in the immediate post-operative period.
  • 7.Since very few patients undergo surgery under spinal +/- epidural anesthesia, these patients will be excluded to avoid too many confounding factors.

结局指标

主要结局

Observation of incidence of CRBD in the post operative period in oncological surgeries where multimodal analgesia is used.

时间窗: In the post-operative period

次要结局

  • 1.To assess the severity of CRBD in the immediate post-operative period (first 24 hrs.)(2.To understand correlation between Morphine Equivalent (ME) for surgical pain and incidence of CRBD in the peri-operative period.)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sumitra Bakshi

Tata Memorial Centre

研究点 (1)

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