Efficacy Of Oral Silodosin During Peri-Operative Period In Preventing Post-Operative Urinary Retention (POUR) In Spine Surgeries - A Randomised Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary outcome is the Incidence of Post operative urinary retention (POUR) in the post operative period after removal of Foleys catheter.
研究概览
简要总结
Post operative urinary retention (POUR) is a frequently encountered post operative event with an incidence ranging from 10%-20% in Orthopaedic surgeries. The rates of POUR has been reported even higher in spine surgeries due to the use of general anesthesia, longer duration of surgery, surgeries involving the lower lumbar levels and old age. With this background we hypothesised that the use of oral silodosin (superselective alpha 1 blocker) can decrease the rate of POUR in patients undergoing spine surgeries.
Hypothesis - The use of super-selective alpha agonist like silodosin in the peri-operative period will reduce the incidence of post operative urinary retention in spine surgeries.
Patients will be randomly allocated into two groups -
**Interventional group (Group 1) -**Tab Silodosin 8mg will be given 8 hours after surgery followed by another dose given 4 hours before the trial voiding. Urinary catheter will be removed on the 1st post operative day.
**Control group (Group 2) -**No additional medication shall be given for urinary retention. However, rest all the medications and protocols will remain the same.
Primary Outcomes assessed - Incidence of Post operative urinary retention
**Benefits -**To provide quality high evidence and improve post operative care in line with concept of ERAS (Early recovery after surgery) and help in preparing a guideline for patients undergoing day care surgery or being discharged early with reduced risk of POUR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients above 18 years of age planned for spine surgery under general anaesthesia were included in the study.
排除标准
- •Patients with neurological deficits, intra-operative dural tear, neurogenic bladder, cauda equina syndrome or conus medullaris syndrome who need indwelling catheter for a longer duration; Patients who are non-ambulatory and need indwelling catheter for longer duration of time. History of urinary retention requiring continuous or intermittent catheterization; Confirmed or suspected urethral stricture, history of prostatic or bladder neck surgery or cases of prostate cancer; History of unstable angina or myocardial infarction or cerebrovascular accidents with residual disease; History of syncope or orthostatic hypotension; An active prescription for an alpha receptor antagonist medication; Impaired renal function serum creatinine more than 1.4 mg/dL or eGFR less than 90 mg/mmol; Chronic Liver disease; Patients taking drugs that is known to have interaction with Silodosin.
- •Clarithromycin, Anti-retroviral drugs, Ketoconazole/Itraconazole; Known allergy to Silodosin; Patients unwilling or unable to give consent.
结局指标
主要结局
Primary outcome is the Incidence of Post operative urinary retention (POUR) in the post operative period after removal of Foleys catheter.
时间窗: 24 hours
次要结局
- Length of stay, Complications, Readmission(30 days)
研究者
Vidyadhara Srinivasa
Manipal Hospital, Old Airport Road, Bangalore