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Bladder DiscomfortNCT04133571

Bladder Irrigation 0.05% Lidocaine Decreases Postoperative CRBD

A study testing 0.05% Lidocaine in people with Bladder Discomfort, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Bladder Discomfort
What is being tested?
0.05% Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
17 May 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Chia-Heng Lin, MD contact

88673121101 ext. 7035

linsofar@yahoo.com.tw

Kuang-I Cheng, MD, PhD. contact

88673121101 ext. 7035

kuaich@kmu.edu.tw

Taiwan1 site, 1 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Chia-Heng Lin, MD, 8863121101 ext. 7035, linsofar@yahoo.com.tw

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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
Being tested
0.05% Lidocaine
Keywords
catheter-related bladder discomfort, lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.05% LidocaineDrug

    Also called intravenous pethidine 0.25 mg/kg

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

Study groups in NCT04133571
Study groupRoleWhat they receive
Control groupNo interventionControl group: using normal saline for bladder irrigation
Study groupExperimentalStudy group: using 0.05% Lidocaine normal saline solution for bladder irrigation
Receives: Drug: 0.05% Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 hours

  2. 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

    Measured: 6 hours

Secondary outcomes (9)

  1. using the sphygmomanometer to monitor blood pressure

    monitoring fluctuate systolic, diastolic blood pressure(unit: mmHg)

    Measured: 6 hours

  2. checking the heart rate of patient by the pulse oximeter

    checking the heart rate(unit: the heart beats per minute) by the pulse oximeter

    Measured: 6 hours

  3. 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

    Measured: 6 hours

  4. checking the physiological response, vomiting or not

    checking vomiting or not

    Measured: 6 hours

  5. 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

    Measured: 6 hours

  6. 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%

    Measured: 6 hours

  7. 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

    Measured: 6 hours

  8. 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

    Measured: 6 hours

  9. 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

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2019
  2. Study start17 May 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133571
Sponsor's protocol ID
KMUHIRB-F(I)-20190065
Status last verified
Feb 2020
First submitted
1 Sep 2019
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 0.05% Lidocaine in people with Bladder Discomfort, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chia-Heng Lin, MD (88673121101 ext. 7035, linsofar@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

using Numerical rating scale to measure pain alleviate (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04133571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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