Intraureteral Lidocaine for Post-Ureteroscopy Pain

November 5, 2013 updated by: Darren Beiko, Queen's University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Centre for Applied Urological Research/Kingston General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Darren Beiko, MD FRCSC
        • Sub-Investigator:
          • Gregory Roberts, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine
Use of lidocaine
Drug: Lidocaine
Use of lidocaine
Placebo Comparator: No lidocaine
No lidocaine/standard of care
Drug: Saline
Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Darren Beiko, MD FRCSC, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lidocaine Beiko

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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