Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

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

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Discomfort
• Intervention / Treatment: Drug: 0.05% Lidocaine

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Heng Lin, MD; Phone Number: 7035 88673121101; Email: linsofar@yahoo.com.tw
• Study Contact Backup: Name: Kuang-I Cheng, MD, PhD.; Phone Number: 7035 88673121101; Email: kuaich@kmu.edu.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • Contact: Chia-Heng Lin, MD; Phone Number: 7035 8863121101; Email: linsofar@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Chia-heng Lin, MD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: lidocaine; catheter-related bladder discomfort
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: KMUHIRB-F(I)-20190065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No