DPNB for Prevention of CRDB

Study Overview
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Brief Summary
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Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.

Detailed Description
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CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia. In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.

Official Title
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Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial

Conditions
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Indwelling Urinary Catheter, Male Patients, General Anesthesia

Intervention / Treatment
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* Procedure: DPNB
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed Male adult patient, aged 18 50 years old, ASA I III Surgery under general anesthesia Exclusion Criteria: Bladder dysfunction, such as overactive bladder A history of bladder outflow obstruction Prostate disease, such as benign prostate hyperplasia, etc. Disturbance of central nervous system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DPNB<br>Patients receive DPNB 30min before extubation at the end of operation. | Procedure: DPNB<br>* Patients receive DPNB 30min before extubation at the end of operation<br>|
| Active Comparator: Tramadol<br>Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation. | Drug: Tramadol<br>* Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of CRBD |  | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) for postoperative pain |  | up to 6 months | 
| Postoperative fentanyl requirement |  | up to 6 months | 
| Side effects | the level of sedation. postoperative nausea vomiting (PONV) incidence of respiratory depression incidence of agitation, and delirium | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Related Bladder Discomfort, Dorsal Penile Nerve Block