Local Anaesthetic and Steroid in the Ureter

• Status: Unknown status
• Trial end date: 2019-12-31

Summary

Précis:

Randomised control trial to evaluate safety and efficacy of intraluminal injection of high pH-high concentration of a long-acting local anesthetic and long-acting glucocorticoid in the ureter after ureteroscopy.

Objectives:

To evaluate a novel method to ameliorate post-ureteroscopy pain in all patients (with and without stents)

Endpoints:

Primary endpoint: mean visual analog pain scale (VAS) post-operatively starting at 1 hour, 4 hours, 8 hours, 24 hours and 7 days post-procedure (minimum of 3 VAS scores). VAS pain, ureteral stent symptoms and analgesic requirement will be assessed at different points during this time period.

Secondary endpoint: Postoperative Nausea/Vomiting (PONV), safety of intraluminal injection of high concentration alkalinized local anaesthetic solution by comparing adverse events between placebo and treatment arms. In addition, rehospitalisation rates and postoperative length of stay will be compared between the three groups.

Population:

150 adult patients undergoing ureteroscopy for ureteric stone disease stratified into negative ureteroscopy and those treated for a stone with or without stent insertion postoperatively Number of Sites: Tallaght Hospital Study Duration: 8 months

• Phase: N/A

Details

• Lead Sponsor: The Adelaide and Meath Hospital, incorporating The National Children's Hospital
• Treatments: Anesthetics; Anesthetics, Local; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Levobupivacaine