Intraureteral Lidocaine for Post-Ureteroscopy Pain
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intraureteral of Alkalinized Lidocaine as Novel Approach to Post-Ureteroscopy Pain: Double-blind Prospective Randomized Controlled Trial|
- Pain as measured by the mean VAS pain score over the study period. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Pain as measured by the mean VAS pain score over the study period. VAS pain, urinary frequency, pain mediation diary and ureteral stent symptoms assessed at different time points during the study. Efficacy will be determined by a 2 or more point mean difference in pain scores between the active treatment group and placebo group.
- Establishment of safety of intraureteral administration of the alkalinized lidocaine solution [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]Comparison of safety parameters (adverse events) between placebo and treatment arm
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Use of lidocaine
Use of lidocaine
Placebo Comparator: No lidocaine
No lidocaine/standard of care
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.
|Contact: Sylvia Robb, RN, CCRP||(613) 548 7800 ext firstname.lastname@example.org|
|Contact: Joseph A Downey, MSc, CCRP||(613) email@example.com|
|Centre for Applied Urological Research/Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 2V7|
|Contact: Angela Black, RN CCRP (613) 549-6666 ext 3848 firstname.lastname@example.org|
|Contact: Joseph Downey, MSc CCRP (613) 548-7832 email@example.com|
|Principal Investigator: Darren Beiko, MD FRCSC|
|Sub-Investigator: Gregory Roberts, MD|
|Principal Investigator:||Darren Beiko, MD FRCSC||Queen's University|