Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

NCT ID: NCT04133571

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-17
• Study Completion Date: 2020-12-31

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

Conditions

Bladder Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Control group: using normal saline for bladder irrigation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group

Study group: using 0.05% Lidocaine normal saline solution for bladder irrigation

Group Type: EXPERIMENTAL

0.05% Lidocaine

Intervention Type: DRUG

0.05% lidocaine with normal saline as a bladder irrigation solution after transurethral surgery intravenous pethidine to decrease CRBD if needed

Interventions

0.05% Lidocaine

0.05% lidocaine with normal saline as a bladder irrigation solution after transurethral surgery intravenous pethidine to decrease CRBD if needed

Intervention Type: DRUG

Other Intervention Names

intravenous pethidine 0.25 mg/kg

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chia-Heng Lin, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chia-heng Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chia-Heng Lin, MD

Role: CONTACT

linsofar@yahoo.com.tw

88673121101 ext. 7035

Kuang-I Cheng, MD, PhD.

Role: CONTACT

kuaich@kmu.edu.tw

88673121101 ext. 7035

Facility Contacts

Chia-Heng Lin, MD

Role: primary

linsofar@yahoo.com.tw

8863121101 ext. 7035

Other Identifiers

KMUHIRB-F(I)-20190065

Identifier Type: -

Identifier Source: org_study_id