Preventing Catheter Related Bladder Discomfort (CRBD) in Male Patients Undergoing Lower Urinary Tract Surgery With Bilateral Pudendal Nerve Block: a Randomized Control Trial
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Catheter related bladder discomfort
研究概览
简要总结
Bladder irrigation with a 3 way foley catheter is an important component of post operative management of transurethral bladder surgeries. But it is associated with a high incidence of bladder discomfort. Catheter related bladder discomfort (CRBD) doesn't respond to the orthodox opioid pain medication and is greatly distressful to the patients postoperatively, adversely affecting the quality of recovery often requiring administration of additional pain medication thereby increasing treatment costs, patient dissatisfaction and longer hospital stays. Several systemic agents have been used to reduce CRBD, but they have many side effects. A trial has been planned to find a way of reducing CRBD avoid distressing systemic side effects
详细描述
INTRODUCTION:
Trans urethral resection of prostate (TURP) and trans urethral resection of bladder tumor (TURBT) are the two most commonly performed endourological procedures associated with complication rates of 10% and 11% respectively.1 This relatively high percentage of complications can be owed to the amount of blood loss that occurs in these surgical procedures and can cause subsequent clot retention. Irrigation attached with three-way large bore urinary catheters is employed in order to avoid this clot retention.2 Catheter related bladder discomfort (CRBD) is a consequence of these large bore urinary catheters irritating the bladder mucosa causing involuntary bladder contractions being mediated by urothelial muscarinic receptors.3 The incidence of CRBD ranges from 47% to 90%.4 CRBD induced by indwelling urinary catheter is characterized by supra-pubic discomfort and a burning sensation in the urethra accompanied by an intense urge to void and increased urinary frequency.5 CRBD doesn't respond to the orthodox opioid pain medication and is greatly distressful to the patients postoperatively, adversely affecting the quality of recovery often requiring administration of additional pain medication thereby increasing treatment costs, patient dissatisfaction and longer hospital stays.3-5 The sensory supply of urethra and bladder neck is carried by Pudendal nerve. It originates from the ventral rami of the anterior nerve roots arising from sacral segments S2 to S4. Therefore theoretically, CRBD can be prevented by applying Pudendal Nerve Block (PNB).5 Xiaoqiang et al in 2017 reported that pudendal nerve block significantly reduced incidence of post-operative CRBD with administration of pudendal nerve block as compared to controls. The frequency of postoperative CRBD was at 63% in PNB versus 82% in control group at 30 minutes which was statistically significant (p=0.004). Similarly, the frequency of CRBD at 2 hours was 64% in PNB and 90% in control group (p˂0.001); and the frequency of CRBD at 8 hours was 58% in PNB and 79% in control group (p=0.003) respectively coinciding with the duration of action of Ropivacaine. Beyond that time there was no statistically significant difference between the two groups.5
RATIONALE:
The rationale of this study is that there is no previous study on this specific topic in the Pakistan. Thus, the findings of my study will help to determine the efficacy of pudendal nerve block in preventing CRBD in our population and will help improve evidence-based practices in patients undergoing TURP and TURBT.
OBJECTIVES:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients.
- •Age >18 years
- •Patients undergoing TURP & TURBT under spinal anesthesia
- •No history of chronic pain
- •ASA I, II & III
排除标准
- •Female gender
- •Ischemic Heart Disease
- •Chronic Obstructive Pulmonary Disease
- •Coagulopathy
- •Mental Disorder
- •ASA IV & V
- •Conversion of spinal anesthesia to general anesthesia
研究组 & 干预措施
Group P
Patients in this group will receive bilateral pudendal nerve block after spinal anesthesia- before starting the surgery
干预措施: pudendal nerve block (Drug)
Group C
Patients in this group will only receive spinal anesthesia before starting the surgery
干预措施: pudendal nerve block (Drug)
结局指标
主要结局
Catheter related bladder discomfort
时间窗: 24 hours post surgery
Frequency of catheter related bladder discomfort at 3,8,12 and 24 hours after surgery
次要结局
- average intensity of Catheter related bladder discomfort(24 hours post surgery)
研究者
arshad khushdil
Principal Investigator
Armed Forces Hospital, Pakistan
