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临床试验/NCT03863743
NCT03863743Unknown不适用

Impact of Integrated Care Pathways for Prevention of Post-operative Urinary Retention in Primary Total Knee or Total Hip Replacement: Prospective Randomized Control Trial

TriHealth Inc.4 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
164
试验地点
4
主要终点
POUR

研究概览

简要总结

A prospective randomized control trial will be conducted at Good Samaritan Hospital and TriHealth Evendale Hospital. Subjects will receive total hip or knee surgery and follow-up via standard care at the discretion of the treating physician or the experimental study arm in which all patients will undergo the integrated care pathway.

详细描述

Patients will be randomized to the control group or the experimental group. Patients in the control group will receive the treating physician's standard of care, and undergo bladder scans in the post anesthesia care unit (PACU), upon admission to the unit, and prior to discharge from the hospital. Patients in the experimental group will undergo a multimodal pain control care pathway that minimizes opioid consumption.

The primary endpoint will be the presence of or absence of post-operative urinary retention (POUR) between discharge from the PACU and prior to discharge from the hospital. POUR will be defined as bladder volume of greater than 500cc and the inability to void for at least 2 hours within the first 24 hours. POUR, once identified will be treated with intermittent straight catheterization (ISC). Secondary endpoints will include opioid consumption (in morphine milligram equivalents; MME), genito-urinary consultation, type (knee or hip) and duration of surgery, type of anesthesia, duration of anesthesia, total amount of IV fluids, blood loss, length of hospital stay (LOS), discharge status (home with early outpatient physical therapy, etc.), time of first spontaneous voiding, and the number of ISCs and any necessary indwelling catheterization and adverse events of interest including POUR, post-operative nausea and vomiting (PONV), severe pain of 7 or greater on the numeric rating scale(NRS), blood loss requiring transfusion, and lower urinary tract symptoms (LUTS).

研究设计

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

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

  • ASA grade I- III
  • BMI under 36 kg/m^2
  • Scheduled surgery for primary total hip or knee replacement
  • Age 18+ years

排除标准

  • Contraindications or failure of neuraxial anesthesia
  • Patients must not be outpatient total hip or knee procedure
  • Known intercurrent UTI, incontinence, or urinary retention not addressed by pre-operative urologic consultation and correction
  • Pregnancy
  • Current nicotine, alcohol or drug abusers
  • Pre-operative narcotic use (any narcotic consumption within 3 days prior to surgery)
  • Post- operative parenteral narcotic administration
  • Allergy or intolerance to liposomal bupivacaine, bupivacaine, celecoxib, dexamethasone and/or pregabalin

结局指标

主要结局

POUR

时间窗: up to 24 hours post-op

presence or absence of urinary retention

次要结局

  • opioid consumption(up to 14 days following the joint procedure)

研究者

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

Mark Snyder

Principal Investigator

TriHealth Inc.

研究点 (4)

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