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Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

K

Kaohsiung Medical University

Status

Unknown

Conditions

Bladder Discomfort

Treatments

Drug: 0.05% Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT04133571
KMUHIRB-F(I)-20190065

Details and patient eligibility

About

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.

Full 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

Enrollment

80 estimated patients

Sex

Male

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Control group
No Intervention group
Description:
Control group: using normal saline for bladder irrigation
Study group
Experimental group
Description:
Study group: using 0.05% Lidocaine normal saline solution for bladder irrigation
Treatment:
Drug: 0.05% Lidocaine

Trial contacts and locations

1

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Central trial contact

Kuang-I Cheng, MD, PhD.; Chia-Heng Lin, MD

Data sourced from clinicaltrials.gov

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