Prostatic Neoplasms Clinical Trial
Official title:
Preventing Catheter Related Bladder Discomfort (CRBD) in Male Patients Undergoing Lower Urinary Tract Surgery With Bilateral Pudendal Nerve Block: a Randomized Control Trial
Verified date | August 2021 |
Source | Armed Forces Hospital, Pakistan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Recruiting |
Enrollment | 250 |
Est. completion date | November 10, 2021 |
Est. primary completion date | November 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Male patients. - Age >18 years - Patients undergoing TURP & TURBT under spinal anesthesia - No history of chronic pain - ASA I, II & III Exclusion Criteria: - Female gender - Ischemic Heart Disease - Chronic Obstructive Pulmonary Disease - Coagulopathy - Mental Disorder - ASA IV & V - Conversion of spinal anesthesia to general anesthesia |
Country | Name | City | State |
---|---|---|---|
Pakistan | Madiha Ahmed | Islamabad |
Lead Sponsor | Collaborator |
---|---|
Armed Forces Hospital, Pakistan |
Pakistan,
Patel HD, Ball MW, Cohen JE, Kates M, Pierorazio PM, Allaf ME. Morbidity of urologic surgical procedures: an analysis of rates, risk factors, and outcomes. Urology. 2015 Mar;85(3):552-9. doi: 10.1016/j.urology.2014.11.034. — View Citation
Xiaoqiang L, Xuerong Z, Juan L, Mathew BS, Xiaorong Y, Qin W, Lili L, Yingying Z, Jun L. Efficacy of pudendal nerve block for alleviation of catheter-related bladder discomfort in male patients undergoing lower urinary tract surgeries: A randomized, controlled, double-blind trial. Medicine (Baltimore). 2017 Dec;96(49):e8932. doi: 10.1097/MD.0000000000008932. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Catheter related bladder discomfort | Frequency of catheter related bladder discomfort at 3,8,12 and 24 hours after surgery | 24 hours post surgery | |
Secondary | average intensity of Catheter related bladder discomfort | average intensity of CRBD using numeric rating scale for pain at 3,8,12 and 24 hours after surgery | 24 hours post surgery |
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