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Intraureteral Lidocaine for Post-Ureteroscopy Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450566
Recruitment Status : Unknown
Verified November 2013 by Darren Beiko, Queen's University.
Recruitment status was:  Recruiting
First Posted : October 12, 2011
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):
Darren Beiko, Queen's University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Ureteral Calculi Renal Calculi Drug: Lidocaine Drug: Saline Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraureteral of Alkalinized Lidocaine as Novel Approach to Post-Ureteroscopy Pain: Double-blind Prospective Randomized Controlled Trial
Study Start Date : September 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lidocaine
Use of lidocaine
Drug: Lidocaine
Use of lidocaine

Placebo Comparator: No lidocaine
No lidocaine/standard of care
Drug: Saline

Primary Outcome Measures :
  1. Pain as measured by the mean VAS pain score over the study period. [ Time Frame: 7 days ]
    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.

Secondary Outcome Measures :
  1. Establishment of safety of intraureteral administration of the alkalinized lidocaine solution [ Time Frame: 7 days ]
    Comparison of safety parameters (adverse events) between placebo and treatment arm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient undergoing URS for treatment of a urinary calculus who requires placement of ureteral stent on a string
  • 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
  • Requires an indwelling stent
  • Pelvic kidney
  • Requires bilateral treatment/stents
  • Previous bladder or ureteral reconstructive surgery
  • Ureteral perforation during procedure
  • Ureteral stenting, within one month of URS
  • Known sensitivity to lidocaine
  • Febrile at time of randomization or treatment
  • Requires spinal anaesthetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450566

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Contact: Sylvia Robb, RN, CCRP (613) 548 7800 ext 3848
Contact: Joseph A Downey, MSc, CCRP (613) 548-7832

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Canada, Ontario
Centre for Applied Urological Research/Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Angela Black, RN CCRP    (613) 549-6666 ext 3848   
Contact: Joseph Downey, MSc CCRP    (613) 548-7832   
Principal Investigator: Darren Beiko, MD FRCSC         
Sub-Investigator: Gregory Roberts, MD         
Sponsors and Collaborators
Queen's University
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Principal Investigator: Darren Beiko, MD FRCSC Queen's University
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Responsible Party: Darren Beiko, Principal Investigator and Associate Professor, Queen's University Identifier: NCT01450566    
Other Study ID Numbers: Lidocaine Beiko
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013
Keywords provided by Darren Beiko, Queen's University:
ureteroscopy (URS)
ureteral stent placement
Ureteral Calculi
Renal Calculi
Additional relevant MeSH terms:
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Kidney Calculi
Ureteral Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urinary Calculi
Ureteral Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action