Comparison Between Preemptive Oral Tapentadol Or Pregabalin For Attenuation Of Catheter Related Bladder Discomfort In Patients Undergoing Transurethral Resection Of Prostate : A Prospective, Randomised, Double Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the incidence of postoperative Catheter Related Bladder Discomfort.
研究概览
简要总结
CRBD is caused by catheter-induced bladder irritation due to muscarinic receptor-mediated
involuntary contractions of the bladder smooth muscle.
Despite the various treatment and prevention options for catheter-related bladder discomfort (CRBD), many uncertainties persist in clinical practice.
Catheter related bladder discomfort being a post catheterization complication has an incidence of 47-90%. This study evaluates the efficacy of preoperative oral Tapentadol or Pregabalin in decreasing the incidence of postoperative catheter-related bladder discomfort in patients undergoing Transurethral Resection of Prostate under Spinal Anaesthesia.
Hence, we are comparing between pre-emptive oral Tapentadol 50 mg or Pregabalin 75 mg for attenuation of
Catheter Related Bladder Discomfort in patients undergoing Transurethral Resection of Prostate
under Spinal Anaesthesia.
Secondary outcome for this study is also being assessed such as the need for additional analgesic and to assess any adverse effects including postoperative nausea and vomiting, respiratory depression, sedation, drowsiness, confusion and dry mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male Age 18 to 80 years ASA I , II , III Undergoing Elective Transurethral resection of Prostate under Regional anaesthesia Requiring bladder catheterization.
排除标准
- •ASA IV patients Contraindication for spinal anaesthesia Significant cardiac disease Chronic analgesic use High AV Block Psychiatric disease Renal failure Paralytic ileus History of urinary tract obstruction/neurogenic/ overactive bladder Acute exacerbation of Bronchial Asthma.
结局指标
主要结局
To assess the incidence of postoperative Catheter Related Bladder Discomfort.
时间窗: 0 minutes | 30 minutes | 1st hour | 2nd hour | 4th hour | 8th hour | 12th hour | 24th hour
次要结局
- Need for additional analgesic.(Assess any adverse effects including postoperative nausea and vomiting, respiratory depression, sedation, drowsiness, confusion and dry mouth.)
研究者
S Ishwarya
Sri Ramachandra Institute Of Higher Education and Research