Intraureteral Lidocaine for Post-Ureteroscopy Pain

This study is currently recruiting participants.
Verified November 2013 by Queen's University
Sponsor:
Information provided by (Responsible Party):
Darren Beiko, Queen's University
ClinicalTrials.gov Identifier:
NCT01450566
First received: September 20, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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 Intervention
Ureteral Calculi
Renal Calculi
Drug: Lidocaine
Drug: Saline

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 48
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)
Arms Assigned Interventions
Experimental: Lidocaine
Use of lidocaine
Drug: Lidocaine
Use of lidocaine
Placebo Comparator: No lidocaine
No lidocaine/standard of care
Drug: Saline
Saline

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450566

Contacts
Contact: Sylvia Robb, RN, CCRP (613) 548 7800 ext 3848 robbs@kgh.kari.net
Contact: Joseph A Downey, MSc, CCRP (613) 548-7832 downeyj@queensu.ca

Locations
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    blacka@kgh.kari.net   
Contact: Joseph Downey, MSc CCRP    (613) 548-7832    downeyj@queensu.ca   
Principal Investigator: Darren Beiko, MD FRCSC         
Sub-Investigator: Gregory Roberts, MD         
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Darren Beiko, MD FRCSC Queen's University
  More Information

No publications provided

Responsible Party: Darren Beiko, Principal Investigator and Associate Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01450566     History of Changes
Other Study ID Numbers: Lidocaine Beiko
Study First Received: September 20, 2011
Last Updated: November 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
ureteroscopy (URS)
ureteral stent placement
Ureteral Calculi
Renal Calculi

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 20, 2014