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临床试验/NCT05022160
NCT05022160Unknown早期 1 期

Preventing Catheter Related Bladder Discomfort (CRBD) in Male Patients Undergoing Lower Urinary Tract Surgery With Bilateral Pudendal Nerve Block: a Randomized Control Trial

Armed Forces Hospital, Pakistan1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年8月10日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
Armed Forces Hospital, Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

arshad khushdil

Principal Investigator

Armed Forces Hospital, Pakistan

研究点 (1)

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