Renal Calculi Clinical Trial
Official title:
Intraureteral of Alkalinized Lidocaine as Novel Approach to Post-Ureteroscopy Pain: Double-blind Prospective Randomized Controlled Trial
Ureteroscopy (URS) is minimally invasive procedure for management of renal stones. URS is
often involves concomitant of an indwelling ureteral stents. Placements of these stents
include pain, bladder irritability, infection, migration, encrustation and stones.
Pain is one of most significant problem of ureteral stents. There are no satisfactory
measures to deal with this problem. A novel approach to manage the pain is to load a drug
onto ureteral stent and deliver the drug into the urinary tract at controlled release rate.
Lidocaine has been proven to be effective for management of the pain associated with
interstitial cystitis. This agent has the potential for management of post-URS pain.
Patients treated with ureteroscopy (URS) for ureteral or renal calculi requiring a ureteral
stent at time of URS will be randomized to receive intraureteral instillation of alkalinized
lidocaine hydrochloride (study group) or normal saline (control group) immediately following
the procedure to assess safety and effectiveness in alleviating pain and stent symptoms.
Thousands of removable stents are placed in patients' ureters (tubes connecting kidney and
bladder) each year in Canada. These plastic stents allow the kidney to drain when there is
swelling after kidney stone surgery or if they are otherwise obstructed. Studies report that
more than 80% of patients have painful symptoms from indwelling ureteral stents. This study
will attempt to show that local anesthetic injected directly into the ureter before stent
placement will reduce stent pain. Recent studies have shown infusing lidocaine with
bicarbonate (a local anesthetic) into painful bladders is safe, and patients' symptoms
improve dramatically. This result inspired the innovative idea that injecting a similar
solution into the kidney and ureter (which have the same lining as the bladder) will numb
the area sufficiently to decrease stent related pain.
The study will randomly select half of the patients to receive an injection of
non-irritating salt water (placebo), and half an injection of pH buffered lidocaine before
the stent is placed. Both patients and physicians will be blinded to the assignment of
treatment or placebo. The investigators will then compare pain scores post operatively.
If successful, future researchers may use lidocaine in drug eluding stents to further
ameliorate pain.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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