Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000860460
Ethics application status
Approved
Date submitted
5/07/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Testing the Safety and Success of Ureteric Stent Insertion Using Local Anaesthesia in Adults with Kidney Stones
Query!
Scientific title
A Pilot Feasibility Study on the Reliability, Safety, and Clinical Efficacy of Ureteric Stent Insertion Under Local Anaesthesia in Patients with Renal Colic
Query!
Secondary ID [1]
314829
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
LAUSI
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Renal colic
338093
0
Query!
Ureteric stones
338094
0
Query!
Kidney stones
338411
0
Query!
Condition category
Condition code
Surgery
334393
334393
0
0
Query!
Surgical techniques
Query!
Renal and Urogenital
334718
334718
0
0
Query!
Other renal and urogenital disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants will undergo ureteric stent insertion under local anaesthesia as a potential alternative to the standard approach using general anaesthesia. This pilot study is being conducted in the Emergency Department (ED) setting at Nepean Hospital for adult patients presenting with renal colic secondary to ureteric obstruction, where decompression is clinically indicated.
Materials Used:
- A Boston Scientific ureteric stent (TGA-approved).
- A Karl Storz flexible cystoscope.
- 2% lignocaine gel (Instillagel) for local anaesthesia.
- Penthrox (methoxyflurane) inhaler will be available as additional analgesia, along with standard renal colic analgesics such as intravenous opioids or NSAIDs, administered as per clinical need.
- Written participant information sheets and informed consent forms will be used prior to the procedure.
- A plain abdominal X-ray will be conducted post-procedure to confirm correct stent placement.
Procedures and Activities:
- Eligible patients presenting to the ED will be screened and consented by the urology team.
- The perineal area will be prepped, and local anaesthetic will be administered intraurethrally.
- A flexible cystoscope will be used to visualise the ureteric orifice, and the ureteric stent will be inserted over a guidewire into the renal pelvis to relieve obstruction.
- Penthrox or other analgesics will be offered as needed during the procedure.
- A post-procedure X-ray will be obtained to confirm stent position.
- Participants will be referred for routine follow-up with a urologist, where formal stone removal (e.g. ureteroscopy or lithotripsy) will be planned as part of standard of care.
Personnel Delivering the Intervention:
- The procedure will be performed by a urology registrar or consultant with a minimum of 3 years’ experience in flexible cystoscopy and ureteric stent placement.
- A trained nurse or procedural assistant will support the procedure and monitor the patient throughout.
Mode and Frequency of Delivery:
- The intervention will be delivered face-to-face, on an individual basis, and will occur once per participant.
- The procedure is expected to take approximately 15 to 30 minutes, including setup, anaesthetic administration, and stent placement.
Location:
- The intervention will take place in the resuscitation bay of the Emergency Department at Nepean Hospital, a metropolitan tertiary referral hospital in Kingswood, Australia.
The intervention will be tailored to individual patient needs:
- The type, dose, and method of local anaesthetic administration may be adjusted based on patient tolerance and anatomical considerations.
- The local anaesthetic typically used will be administration of 11mL Installagel (2% w/w Lidocaine Hydrochloride) within the urethra (for males) or along the cytoscope (for females)
- Analgesia (e.g. Penthrox, opioids, NSAIDs (ibuprofen/nurofen)) will be titrated according to pain levels before, during, and after the procedure.
- All adaptations will be determined in real time by the treating urologist based on clinical judgement and patient feedback.
Adherence and fidelity will be maintained through the following:
- Completion of a standardised procedural checklist by the proceduralist after each case, detailing anaesthesia, procedural steps, analgesia use, and any deviations.
- Independent review of a random selection of cases by the study coordinator to ensure compliance with protocol.
- Initial supervision by a consultant urologist for early cases, with structured interim reviews after the first 3 and first 10 patients to ensure safety and consistency.
- Regular feedback to proceduralists and reinforcement of the study protocol during team briefings.
These strategies are designed to maintain consistency across cases while allowing clinical flexibility to prioritise patient comfort and safety.
Query!
Intervention code [1]
331433
0
Treatment: Surgery
Query!
Comparator / control treatment
N/A
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
342074
0
Technical success rate of ureteric stent insertion under local anaesthesia
Query!
Assessment method [1]
342074
0
The proceduralist will complete a standardised procedural checklist immediately after the intervention, confirming: - Whether the stent was successfully inserted under local anaesthesia; - Whether conversion to general anaesthesia or abandonment occurred; - Any procedural complications encountered. Technical success will be determined based on: - Visual confirmation of correct stent placement during cystoscopy; - Confirmation on post-procedure plain abdominal X-ray; - No requirement for further immediate intervention to complete the stent insertion. Completion of the standardised procedural checklist and the technical success checklist will be assessed together as a composite primary outcome.
Query!
Timepoint [1]
342074
0
Immediately post-procedure - The outcome will be assessed at the conclusion of the ureteric stent insertion procedure, once the stent position is confirmed on X-ray and the proceduralist completes the standardised checklist.
Query!
Secondary outcome [1]
449473
0
Participant-reported experience and satisfaction following ureteric stent insertion under local anaesthesia
Query!
Assessment method [1]
449473
0
Participant experience will be assessed using a standardised post-procedure questionnaire, completed within 4 hours after the procedure during the same emergency department presentation. The questionnaire includes: - Numerical pain rating scale (0–10) during the procedure and at the time of completing the form. - Tolerability rating (Very well / Well / Neutral / Poorly / Very poorly). - Overall experience rating (Excellent / Good / Fair / Poor / Very poor). - Open-ended free-text box for any remaining concerns or feedback. The form will be administered face-to-face by a member of the research team. Responses will be reviewed and entered into a secure study database. Patients pain, tolerance and overall experience of the procedure will be assessed together as a composite secondary outcome.
Query!
Timepoint [1]
449473
0
Participant responses will be collected before discharge from the Emergency Department, within 4 hours of the stent being placed and post-procedure imaging being completed.
Query!
Secondary outcome [2]
449474
0
Incidence of adverse events and complications related to ureteric stent insertion under local anaesthesia
Query!
Assessment method [2]
449474
0
Clinical safety will be assessed by: - Real-time documentation of any intra-procedural or immediate post-procedural adverse events by the proceduralist using a standardised complication reporting form. - Monitoring for events such as: - Inability to complete the procedure due to patient discomfort or technical failure - Mucosal trauma or urethral injury - Significant haematuria - Infection (e.g. fever, sepsis) - Retained or malpositioned stent - Need for unplanned escalation of care (e.g. conversion to general anaesthesia, theatre, admission to ward) Post-procedural follow-up review by the urology team as part of routine care, including the scheduled outpatient appointment for definitive stone management (e.g. ureteroscopy or lithotripsy). Any delayed complications identified at follow-up will also be recorded. Data regarding complications will be captured by a patient questionnaire completed at the follow-up visit. Complication data will be reviewed and recorded by the study team using predefined criteria, and classified by severity where applicable (e.g. Clavien-Dindo grading).
Query!
Timepoint [2]
449474
0
During ED stay and up to first urology outpatient follow-up Complications will be assessed: - Immediately during and after the procedure while in the Emergency Department; and - At the first scheduled outpatient urology follow-up, typically within 1 to 4 weeks post-procedure, as part of routine stone management.
Query!
Secondary outcome [3]
449475
0
Satisfaction of urology doctors with the ease and overall experience of ureteric stent insertion under local anaesthesia
Query!
Assessment method [3]
449475
0
Doctor satisfaction will be assessed using a standardised post-procedure questionnaire, completed immediately after each stent insertion. The questionnaire includes: - Perceived patient tolerability, rated on a 5-point Likert scale (Very well to Very poorly). - Free-text report of any difficulties or complications encountered during the procedure. - Overall rating of the procedure, on a 0–10 numerical scale. - Open-ended comments section for additional feedback or suggestions. The form will be completed by the proceduralist (urology registrar or consultant) and submitted to the study team for review. Responses will be used to evaluate clinician-perceived feasibility, comfort, and usability of the local anaesthetic approach in the ED setting. The above described clinical satification metrics will be assessed as a composite secondary outcome.
Query!
Timepoint [3]
449475
0
Immediately post-procedure
Query!
Secondary outcome [4]
449476
0
Feasibility of participant recruitment, including enrolment rate and reasons for non-participation
Query!
Assessment method [4]
449476
0
Feasibility will be assessed using a prospectively maintained recruitment log documenting: - Total number of eligible patients approached for participation - Number and proportion of patients who consented and were enrolled (assessed via audit of recruitment data) - Number and proportion of patients who declined participation (assessed via audit of de-identified logs of patients offered enrollment onto the trial) - Stated reasons for refusal, if offered (e.g. pain, anxiety, preference for general anaesthetic, inability to consent) Any logistical issues affecting recruitment (e.g. staffing, timing, lack of ED availability) The above feasibility measures will be assessed as a composite secondary outcome.
Query!
Timepoint [4]
449476
0
Cumulative data will be assessed at the conclusion of the study.
Query!
Secondary outcome [5]
449477
0
Impact of ureteric stent insertion under local anaesthesia on emergency department and urology workflow
Query!
Assessment method [5]
449477
0
Workflow impact will be assessed using a procedural log and clinician-reported data, including: - Time from decision-to-stent to procedure start (minutes) - Procedure duration: From setup to completion (minutes) - Total time spent in the ED from presentation to stent completion - Any workflow disruptions, delays, or competing demands noted by the procedural team - Free-text clinician feedback collected via the doctor questionnaire (Item 8: "Other comments") These metrics will be documented by the proceduralist or study coordinator at the time of the procedure and reviewed by the research team to evaluate the practicality of integrating local anaesthetic stenting into routine emergency workflows. All the impact measures described above will be assessed together as a composite secondary outcome.
Query!
Timepoint [5]
449477
0
Workflow data will be recorded during or immediately after each stent insertion procedure.
Query!
Secondary outcome [6]
449478
0
Health economic impact of ureteric stent insertion under local anaesthesia compared to standard approaches
Query!
Assessment method [6]
449478
0
A health economic analysis will be conducted using data collected during the study and compared to published or local retrospective data on traditional stent insertion under general anaesthesia. The analysis will include: - Direct hospital costs, including: - ED bed time for local anaesthetic stenting procedures - Staff time (nursing, medical) - Equipment and consumables used Avoided theatre costs, including: - Operating room time - Anaesthetic staffing and resources - Recovery unit use - Length of hospital stay, where applicable Resource use comparisons between local anaesthetic stenting and historical standard-of-care procedures (e.g. costs of admission, analgesic requirements, post-procedural recovery) Cost estimates will be derived from hospital finance data, staffing rosters, and national cost weights where applicable, such as the NBMLHD funding and performance supplement, NBMLHD expense budget and AIHW health expenditure reports.
Query!
Timepoint [6]
449478
0
End of study recruitment and data collection period
Query!
Eligibility
Key inclusion criteria
1. Consenting adult participant male or female, age > 18 years old
2. Patient who has presented to ED with acute renal colic requiring admission to hospital for a ureteric stent
3. Ability to provide informed consent by study participant
4. Willingness and ability to comply with study-related procedures/assessments
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Age <18
2. Known allergy to local anaesthetic lubricating gel
3. Known allergy to Penthrox temporary anaesthetic inhaler
4. Stone larger than 1 cm
5. Stone impacted in ureter
6. Men with prostate larger than 100cc in size
7. Haemodynamically unstable
8. Participant with severe sepsis requiring nephrostomy or stabilisation in an operating room
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
1/09/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
1/09/2026
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Funding & Sponsors
Funding source category [1]
319388
0
Hospital
Query!
Name [1]
319388
0
Nepean Hospital
Query!
Address [1]
319388
0
Query!
Country [1]
319388
0
Australia
Query!
Funding source category [2]
319614
0
Other Collaborative groups
Query!
Name [2]
319614
0
Nepean Urology Research Group
Query!
Address [2]
319614
0
Query!
Country [2]
319614
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Nepean and Blue Mountains Local Health District
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
321874
0
Other Collaborative groups
Query!
Name [1]
321874
0
Nepean Urology Research Group
Query!
Address [1]
321874
0
Query!
Country [1]
321874
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
317962
0
Nepean Blue Mountains Local Health District
Query!
Ethics committee address [1]
317962
0
https://www.nbmlhd.health.nsw.gov.au/researchoffice
Query!
Ethics committee country [1]
317962
0
Australia
Query!
Date submitted for ethics approval [1]
317962
0
18/03/2025
Query!
Approval date [1]
317962
0
20/06/2025
Query!
Ethics approval number [1]
317962
0
Query!
Summary
Brief summary
This study aims to test whether inserting a ureteric stent — a small tube used to relieve kidney blockage caused by kidney stones — can be done safely and effectively using local anaesthesia in the emergency department, instead of general anaesthesia in the operating theatre. We are inviting adults who come to hospital with kidney stone pain requiring stent placement to take part. The procedure will be done using numbing gel and other local pain relief, with additional medications like Penthrox (green whistle) available if needed. We will assess whether the procedure can be successfully completed under local anaesthesia, how well patients tolerate it, and how satisfied both patients and doctors are with the experience. The study will also look at the impact on hospital workflow, resource use, and cost. We hope this approach could offer a quicker, simpler, and more efficient alternative to standard care, especially in busy emergency settings.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
142702
0
Dr Isaac Thangasamy
Query!
Address
142702
0
Nepean Hospital, Somerset St, Kingswood NSW 2747
Query!
Country
142702
0
Australia
Query!
Phone
142702
0
+61 400 994 387
Query!
Fax
142702
0
Query!
Email
142702
0
[email protected]
Query!
Contact person for public queries
Name
142703
0
Ymer Bushati
Query!
Address
142703
0
Nepean Hospital, Somerset St, Kingswood NSW 2747
Query!
Country
142703
0
Australia
Query!
Phone
142703
0
+61 415 991 306
Query!
Fax
142703
0
Query!
Email
142703
0
[email protected]
Query!
Contact person for scientific queries
Name
142704
0
Ymer Bushati
Query!
Address
142704
0
Nepean Hospital, Somerset St, Kingswood NSW 2747
Query!
Country
142704
0
Australia
Query!
Phone
142704
0
+61 415 991 306
Query!
Fax
142704
0
Query!
Email
142704
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
Patient Informed Consent Form.docx
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.
Download to PDF