Local Anaesthetic and Steroid in the Ureter

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Any patient undergoing ureteroscopy for ureteric stone disease

• Able to undergo a general anaesthetic

• At least 18 years old

• Willing and able to complete patient symptom questionnaires

Exclusion Criteria:

• Solitary Kidney

• Renal failure

• Anatomic bladder or ureteral abnormality

• Uncorrected coagulopathy

• Previous cystectomy or urinary diversion

• Neurogenic bladder

• Interstitial cystitis

• Transplanted kidney

• Pregnancy

• Requires an indwelling catheter

• Recurrent urinary tract infections

• Pelvic kidney

• Requires bilateral treatment/stents

• Previous bladder or ureteral reconstructive surgery

• Ureteral perforation during procedure

• Known sensitivity to lidocaine

• Febrile at time of randomization or treatment

• Requires spinal anaesthetic

• Stenting without stone treatment