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临床试验/NCT03453866
NCT03453866已完成不适用

Effect of Warmed Irrigation Fluid on Immediate Post-operative Pain Scores in Patients Undergoing Hip Arthroscopy

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Changes in Visual Analog Score

研究概览

简要总结

The purpose of this study is to determine if pre-warming of arthroscopic fluid reduces immediate post-surgical pain in hip arthroscopy patients. The investigators hypothesize there will be a significant decrease in the Visual Analog Score (VAS) measured 30 minutes post-operatively in the warmed fluid group compared to the control group. Secondary outcome measures to be collected will include VAS scores 60 minutes after surgery and on post-operative day (POD) one. Additionally, the investigators will collect post-operative temperature measured 30 and 60 minutes post-operatively as well as morphine equivalent dosing in PACU and at the two-week follow up visit.

详细描述

In the last two decades, hip arthroscopy for the treatment of femoral acetabular impingement has increased rapidly. Currently, over 30k hip scopes are performed annually in the United States (incidence 1.06 per 10K). Due to anatomical differences, hip arthroscopy procedures have the potential for significant fluid extravasation when compared to knee arthroscopy. A 2011 study on hip arthroscopy showed on average 9.68 liters of fluid were used for a standard hip procedure; of that 1.13 liters absorbed into the surrounding soft tissues. A recent systematic review and meta-analysis showed warming of arthroscopic fluids significantly decreased the risk of hypothermia during hip arthroscopy. Additionally, active warming has been shown to decrease the rate of surgical site infection during numerous procedures. In total knee arthroplasty patients, a forced air warming gown significantly reduced narcotic pain consumption compared to standard care. However, the benefits of active warming for decreasing post-operative pain has not been studied in hip arthroscopy patients. Specifically, the investigators were interested in the roll the pre-warming arthroscopic fluid plays in post-operative pain after hip arthroscopy. The purpose of this study is to see if pre-warming of arthroscopic fluid reduces immediate post-surgical pain and narcotic consumption in hip arthroscopy patients.

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
Double (Participant, Outcomes Assessor)

盲法说明

Sealed Opaque Envelope

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients aged 18-65 years with a confirmed diagnosis of Femoroacetabular impingement (FAI)
  • •Required hip arthroscopy will be considered for the study
  • •Pre-operative history and physical exam
  • •Magnetic resonance imaging (MRI) before being indicated for arthroscopic surgery

排除标准

  • •Taking narcotic medications at baseline
  • •Have a history of complex regional pain syndrome,
  • •Have hip arthritis,
  • •Have undergone previous hip arthroscopic surgery, or
  • •Are deemed incapable by the Principal Investigator of completing the study.

研究组 & 干预措施

Warmed Arthroscopic Fluids

Experimental

Arthroscopic Fluids will be warmed to 38 degrees Celsius during procedure with active warming device. Temperature will be measured in real time.

干预措施: Warmed Arthroscopic Fluids (Procedure)

Room Temperature Arthroscopic Fluids

Active Comparator

Arthroscopic fluids will be kept at room temperature and will not be warmed per current standard of care. Temperature will be measured in real time.

干预措施: Room Temperature Arthroscopic Fluids (Procedure)

结局指标

主要结局

Changes in Visual Analog Score

时间窗: Pre-operatively, 30 and 60 minutes after completion of surgery, Post Op Days 1 and 14.

A Visual Analog Score (VAS) will be measured pre-operatively, 30 and 60 minutes after patient arrival in the post-anesthesia care unit (PACU). Additionally, VAS will be collected in the clinic on post-operative day (POD) 1 and POD 14. The visual analog scale measures subject reported pain on a scale of 0-100 with a score of 0 indicating no pain and 100 indicating the worst pain possible.

次要结局

  • Changes in Temperature(30-60 minutes after after completion of surgery)
  • Morphine Equivalent Dosage (MED)(After completion of surgery and at the 2-week Post Operative Visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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