Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000122550
Ethics application status
Approved
Date submitted
3/04/2006
Date registered
5/04/2006
Date last updated
5/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Delayed versus immediate urethral catheterization following instillation of local anaesthetic gel in males: a Randomized Clinical Trial
Scientific title
Pain experienced with delayed versus immediate urethral catheterization following instillation of local anaesthetic gel in males with urinary retention or the need for monitoring of urine output: a Randomized Clinical Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary retention, and the need for monitoring of urine output 1087 0
Condition category
Condition code
Anaesthesiology 1167 1167 0 0
Pain management
Renal and Urogenital 1168 1168 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following the instillation of standard local anaesthetic gel (lignocaine) into the urethra, participants will be catheterised immediately.
Intervention code [1] 966 0
Treatment: Other
Comparator / control treatment
Following the instillation of standard local anaesthetic gel (lignocaine) into the urethra, participants will be catheterised following a 2-minute delay.
Control group
Active

Outcomes
Primary outcome [1] 1572 0
The pain of catheterisation experienced during the procedure
Timepoint [1] 1572 0
Measured immediately following the procedure
Secondary outcome [1] 2848 0
Adverse events, for example bleeding, failure to catheterise.
Timepoint [1] 2848 0
These will be measured immediately following the procedure.

Eligibility
Key inclusion criteria
Require urethral catheterisation.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to lignocaine, known abnormal urethral anatomy, inability to assess pain (altered mental state, dementia, language barrier), significant illness associated with pain or discomfort, trauma patients, spinal patients, patients who have received narcotic analgesia in previous 4 hours, patient refusal or inability to give consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation for each of four sites, as generated by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1276 0
Hospital
Name [1] 1276 0
Royal Melbourne Hospital
Country [1] 1276 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 1130 0
None
Name [1] 1130 0
Nil
Address [1] 1130 0
Country [1] 1130 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
We aim to show if introducing a delay between instillation of local anaesthetic gel into the urethra and the performance of catheterisation produces less discomfort than immediate catheterisation.

The assessor who administers the pain scale rating will be blinded to the assignment of the patient (delayed or immediate catheterisation). The participant and proceduralist will not be blinded to the assignment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35519 0
Address 35519 0
Country 35519 0
Phone 35519 0
Fax 35519 0
Email 35519 0
Contact person for public queries
Name 10155 0
Robert Garbutt
Address 10155 0
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3052
Country 10155 0
Australia
Phone 10155 0
+61 3 93427009
Fax 10155 0
Email 10155 0
[email protected]
Contact person for scientific queries
Name 1083 0
Robert Garbutt
Address 1083 0
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3052
Country 1083 0
Australia
Phone 1083 0
+61 3 93427009
Fax 1083 0
Email 1083 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.