The Use of a Routine Indwelling Urinary Catheter in Patients Receiving Neuraxial Anesthesia for Elective Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr
研究概览
简要总结
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post void residuals, and postoperative urinary tract infection. Treatment of urinary retention involves intermittent or indwelling urinary catheter placement, both of which are associated with an increased prevalence of postoperative urinary tract infection.
There currently is no consensus whether the use of a urinary catheter in elective joint arthroplasty with neuraxial anesthesia decreases the risk of urinary retention. The prevalence of retention reported in the literature varies widely with reports anywhere from 0% to 75% in patients with early removal of a catheter or after procedures performed without a catheter.
The goal of this study is to determine whether the routine use of an indwelling urinary catheter decreases the rate of postoperative urinary retention in patients undergoing elective joint arthroplasty.
详细描述
Study Design
Treatment Groups:
Group 1 (Control): Short term urinary catheter- Patient will receive a urinary catheter at the time of the surgery. The urinary catheter will be removed upon arrival to the orthopedic floor post operatively. Patients will subsequently be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol.
Group 2 (Experimental): No urinary catheter- Patients will not receive a urinary catheter at time of surgery. They will be monitored for urinary retention according to the Rush University Medical Center urinary retention protocol
Sample Size Calculation Based on a randomized controlled trial published by Miller et al in 2013, to detect a clinically significant difference of 7%, we would need 194 patients per group, or 388 patients. Assuming a drop-out rate of 10%, a total of 432 patients will be required. An interim analysis will be performed once half of this total is enrolled.
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
- Single (Participant)
盲法说明
The participant (patient) will be blinded to whether they are receiving a short-term foley catheter or no foley.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient >18 years of age scheduled for an inpatient primary hip or knee replacement
排除标准
- •Patients with a known history of prostate, urological or kidney surgery
- •Patients where close monitoring of urine output are necessary during the perioperative period (renal disease, renal failure, chronic indwelling urinary catheter)
- •Patients with a history of urinary incontinence
- •Patients undergoing a revision total knee or total hip arthroplasty
- •Patients requiring indwelling continuous epidural anesthesia
- •Patients with a preexisting urinary tract infection, as diagnosed on preoperative screening.
研究组 & 干预措施
Indwelling foley catheter
Short-term indwelling foley catheter
干预措施: Indwelling foley catheter (Device)
No Foley catheter
No foley catheter
干预措施: No foley catheter (Other)
结局指标
主要结局
Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr
时间窗: While inpatient following surgery
All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straight catheterization (per hospital protocol), meant they developed POUR following surgery.
次要结局
- Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty(up to 3 weeks after surgery)
- Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty(While inpatient at hospital, immediately following surgery)
研究者
Craig J Della Valle, MD
Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction
Rush University Medical Center