Clinical trial NCT04133571: Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD
Official title: Bladder Irrigation With 0.05% Lidocaine Normal Saline Solution for Prevent Postoperative Catheter Related Bladder Discomfort (CRBD) Under ANI Monition After Transurethal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Discomfort
Keywords: catheter-related bladder discomfort
lidocaine
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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:

1. to evaluate the efficacy to prevent CRBD with Bladder irrigation with 0.05% Lidocaine normal saline solution
2. to observe the change of vital sign with Bladder irrigation with 0.05% Lidocaine normal saline solution
3. to see the side effect of with Bladder irrigation with 0.05% Lidocaine normal saline solution

Eligibility criteria: 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

Primary outcomes:
measure: using Numerical rating scale to measure pain alleviate
timeFrame: 6 hours
measure: using catheter-related bladder discomfort score to evaluate CRBD alleviation
timeFrame: 6 hours
Secondary outcomes:
measure: using the sphygmomanometer to monitor blood pressure
timeFrame: 6 hours
measure: checking the heart rate of patient by the pulse oximeter
timeFrame: 6 hours
measure: monitoring the hemodynamic changes by using the analgesia nociception index(ANI)
timeFrame: 6 hours
measure: checking the physiological response, vomiting or not
timeFrame: 6 hours
measure: measure the physiological response to the hypothermia of patient
timeFrame: 6 hours
measure: measuring the amount of oxygen in the blood
timeFrame: 6 hours
measure: assess the electrolyte imbalance by checking the content of Na
timeFrame: 6 hours
measure: assess the electrolyte imbalance by checking the content of K
timeFrame: 6 hours
measure: assess the electrolyte imbalance by checking the content of Ca++
timeFrame: 6 hours
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Chia-heng Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: