Intraureteral Lidocaine for Post-Ureteroscopy Pain
Primary Purpose
Ureteral Calculi, Renal Calculi
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Ureteral Calculi focused on measuring ureteroscopy (URS), ureteral stent placement, Ureteral Calculi, Renal Calculi
Eligibility 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
Sites / Locations
- Centre for Applied Urological Research/Kingston General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lidocaine
No lidocaine
Arm Description
Use of lidocaine
No lidocaine/standard of care
Outcomes
Primary Outcome Measures
Pain as measured by the mean VAS pain score over the study period.
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
Comparison of safety parameters (adverse events) between placebo and treatment arm
Full Information
NCT ID
NCT01450566
First Posted
September 20, 2011
Last Updated
November 5, 2013
Sponsor
Queen's University
1. Study Identification
Unique Protocol Identification Number
NCT01450566
Brief Title
Intraureteral Lidocaine for Post-Ureteroscopy Pain
Official Title
Intraureteral of Alkalinized Lidocaine as Novel Approach to Post-Ureteroscopy Pain: Double-blind Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi, Renal Calculi
Keywords
ureteroscopy (URS), ureteral stent placement, Ureteral Calculi, Renal Calculi
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Use of lidocaine
Arm Title
No lidocaine
Arm Type
Placebo Comparator
Arm Description
No lidocaine/standard of care
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Use of lidocaine
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Pain as measured by the mean VAS pain score over the study period.
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Establishment of safety of intraureteral administration of the alkalinized lidocaine solution
Description
Comparison of safety parameters (adverse events) between placebo and treatment arm
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvia Robb, RN, CCRP
Phone
(613) 548 7800
Ext
3848
Email
robbs@kgh.kari.net
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph A Downey, MSc, CCRP
Phone
(613) 548-7832
Email
downeyj@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darren Beiko, MD FRCSC
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Applied Urological Research/Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Black, RN CCRP
Phone
(613) 549-6666
Ext
3848
Email
blacka@kgh.kari.net
First Name & Middle Initial & Last Name & Degree
Joseph Downey, MSc CCRP
Phone
(613) 548-7832
Email
downeyj@queensu.ca
First Name & Middle Initial & Last Name & Degree
Darren Beiko, MD FRCSC
First Name & Middle Initial & Last Name & Degree
Gregory Roberts, MD
12. IPD Sharing Statement
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Intraureteral Lidocaine for Post-Ureteroscopy Pain
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