None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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