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临床试验/NCT03564886
NCT03564886已完成4 期

Safety and Efficacy of Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年1月1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
已完成
入组人数
48
试验地点
1
主要终点
Fluid Extravasation

研究概览

简要总结

An isotonic solution, such as saline (0.9%, 300mOsm/L) or lactated ringer's (273 mOsm/L), is commonly used and safely proven for joint irrigation during arthroscopy. Arthroscopic fluid is usually pressurized to enable visualization through dilation of the joint or bursa and prevent bleeding from the microvasculature. It has been recommended that this pressure be maintained at 49mmHg or less below the systolic blood pressure to preserve the clarity of view. The combination of large amounts of pressurized irrigation solution and lengthy arthroscopic procedures may cause substantial tissue fluid retention. Thus, extravasation of irrigation fluid into the periarticular tissues is inevitable and may create technical difficulties as well as patient morbidity and complications. Previous investigators have reported complications including tracheal obstruction, post-operative airway edema and compromise leading to prolonged intubation, excess weight gain, neurologic injuries, skin necrosis, and fluid overload associated with excessive fluid extravasation and tissue retention. Furthermore, it has been shown that fluid accumulated during the operation is slowly released back into the systemic circulation. Although there is not a rapid change in circulating volume, there may be implications for elderly patients and those with multiple comorbidities during prolonged arthroscopic surgery. Therefore the investigators seek to determine if a hyperosmolar solution, similar to what is used in head trauma patients, can reduce the degree of fluid extravasation in knee arthroscopy. The investigators also seek to determine if a hyperosmolar solution has any effect on post-operative knee pain compared to the standard isotonic solution. The third objective is to determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who are willing and able to consent.

排除标准

  • Current pregnancy or breastfeeding
  • Unable to give consent
  • Mentally Disabled

研究组 & 干预措施

Hyperosmolar Saline

Experimental

The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.

干预措施: Hyperosmolar Saline (Drug)

Normal Saline

Placebo Comparator

Lactate Ringer's (LR, 273mOsm/L) is commonly used at our facility as our isotonic standard irrigation solution and will serve as the control to be evaluated against a hyperosmolar (1.9%, 600mOsm) solution.

干预措施: Normal saline (Drug)

结局指标

主要结局

Fluid Extravasation

时间窗: Immediately Postoperatively

To determine if a hyperosmolar solution, similar to what is used in head trauma patients, can change the degree of fluid extravasation in knee arthroscopy.

次要结局

  • Opioid Consumption(Postoperative Days 1, 2 and 3.)
  • Postoperative Pain(Post-operative Days 1, 2 and 3)

研究者

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

James Stannard

Hansjörg Wyss Distinguished Chair in Orthopaedic Surgery

University of Missouri-Columbia

研究点 (1)

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