Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

Study Overview
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Brief Summary
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Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing, and it may get worse in patients undergoing transurethral surgery for damage urethra by a surgical instrument as well as a sizable and urinary catheter placement. Lidocaine, a local anesthetic, showed of analgesic, sedative, and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort.

Detailed Description
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Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is very distressing. It is not unusual that patients who have been catheterized under anesthesia complain of an urge to void in the postoperative period because of catheter-related bladder irritation. Bladder catheterization induces bladder irritation whose symptoms (urge to void and discomfort in the suprapubic region) are similar to the symptoms of an overactive bladder (urinary frequency and urgency with or without urge incontinence), caused by involuntary contractions of the bladder mediated by muscarinic receptors. The discomforts are quickly getting worse in patients undergoing transurethral surgery by a surgical instrument as well as a sizable urinary catheter placement. Recently, antimuscarinic drugs for treat overactive bladder, such as tolterodine and oxybutynin, have been tried for prevention of CRBD with variable success. However, they may cause side effect including palpitation, dry mouth, drowsiness, dizziness or headache. Lidocaine, a local anesthetic, showed of analgesic, sedative and anti-inflammatory effect. Therefore, the investigators prepared a 0.05% lidocaine in normal saline as a bladder irrigation solution after surgery to reduce Catheter-related bladder discomfort. Objectives: The aim of this study were: to evaluate the efficacy to prevent CRBD with Bladder irrigation with 0.05% Lidocaine normal saline solution to observe the change of vital sign with Bladder irrigation with 0.05% Lidocaine normal saline solution to see the side effect of with Bladder irrigation with 0.05% Lidocaine normal saline solution

Official Title
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Bladder Irrigation With 0.05% Lidocaine Normal Saline Solution for Prevent Postoperative Catheter Related Bladder Discomfort (CRBD) Under ANI Monition After Transurethal Surgery

Conditions
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Bladder Discomfort

Intervention / Treatment
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* Drug: 0.05% Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received regular transurethral surgery were inserted left foley catheter for urine drainage or bladder irrigation. American Society of Anesthesiologists(ASA)class:Ι-Ⅲ Age:20-70years Sex:Male Exclusion Criteria: Lidocaine allergy cardiac conduction with partial or total block patient with progressive hepatic or renal impairment patient with class III anti-arrhythmia agent(ex:amiodarone) patient with acute porphyria

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group: using normal saline for bladder irrigation | |
| Experimental: Study group<br>Study group: using 0.05% Lidocaine normal saline solution for bladder irrigation | Drug: 0.05% Lidocaine<br>* 0.05% lidocaine with normal saline as a bladder irrigation solution after transurethral surgery intravenous pethidine to decrease CRBD if needed<br>* Other names: intravenous pethidine 0.25 mg/kg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| using Numerical rating scale to measure pain alleviate | measurement of numerical pain rating scale from 0 (no pain): no pain to 10 (severe pain intolerable) as maintain the score of analgesia nociception index within 50-70 ( over 70 may need to evaluate analgesia overdose and under 50 to evaluate pain or hemodynamic changes) | 6 hours | 
| using catheter-related bladder discomfort score to evaluate CRBD alleviation | measurement of catheter-related bladder discomfort score (grade 1: none, grade II: mild, grade III: moderate, grade IV: severe | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| using the sphygmomanometer to monitor blood pressure | monitoring fluctuate systolic, diastolic blood pressure(unit: mmHg) | 6 hours | 
| checking the heart rate of patient by the pulse oximeter | checking the heart rate(unit: the heart beats per minute) by the pulse oximeter | 6 hours | 
| monitoring the hemodynamic changes by using the analgesia nociception index(ANI) | maintain the score of analgesia nociception index within 50-70 ( over 70 may need to evaluate analgesia overdose and under 50 to evaluate pain or hemodynamic changes) and observe the changes under the situation of discomfort and pain | 6 hours | 
| checking the physiological response, vomiting or not | checking vomiting or not | 6 hours | 
| measure the physiological response to the hypothermia of patient | measure if the temperature below 35.0°C so called the hypothermia(unit: °C) of patient by the thermometer | 6 hours | 
| measuring the amount of oxygen in the blood | check SaO2(arterial oxygen saturation) by the pulse oximeter(unit: %), a small beams of light pass through the blood in the finger, measuring the amount of oxygen, should maintain in 90%-100% | 6 hours | 
| assess the electrolyte imbalance by checking the content of Na | assess the electrolyte imbalance, maintain Na(unit: mmol/L) in 135-145, by 2 to 5 ml of blood testing | 6 hours | 
| assess the electrolyte imbalance by checking the content of K | assess the electrolyte imbalance, maintain K(unit: mmol/L) in 3.5-5.1, by 2 to 5 ml of blood testing | 6 hours | 
| assess the electrolyte imbalance by checking the content of Ca++ | assess the electrolyte imbalance, maintain Ca++(unit: mg/dL) in 4.6 5.32, by 2 to 5 ml of blood testing | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter-related bladder discomfort, lidocaine