Ureteral CalculiNCT01450566
Intraureteral Lidocaine for Post-Ureteroscopy Pain
A study testing Lidocaine and Saline in people with Ureteral Calculi and Renal Calculi, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Calculi, Renal Calculi
- What is being tested?
- Lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Solitary Kidney
- Renal failure
- Anatomic bladder or ureteral abnormality
- Uncorrected coagulopathy
- Previous cystectomy or urinary diversion
- Neurogenic bladder
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Applied Urological Research/Kingston General Hospital
Kingston, Ontario, K7L 2V7
Angela Black, RN CCRP, (613) 549-6666 ext. 3848, blacka@kgh.kari.net
Joseph Downey, MSc CCRP, (613) 548-7832, downeyj@queensu.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Ureteral Calculi, Renal Calculi
- Being tested
- Lidocaine, Saline
- Keywords
- ureteroscopy (URS), ureteral stent placement, Ureteral Calculi, Renal Calculi
- Medical subject headings
- Ureteral Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Use of lidocaine
SalineDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Use of lidocaine Receives: Drug: Lidocaine |
| No lidocaine | Placebo comparator | No lidocaine/standard of care Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
Establishment of safety of intraureteral administration of the alkalinized lidocaine solution
Comparison of safety parameters (adverse events) between placebo and treatment arm
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Beiko, Queen's University
- Investigators
- Darren Beiko, MD FRCSC, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450566
- Sponsor's protocol ID
- Lidocaine Beiko
- Status last verified
- Nov 2013
- First submitted
- 20 Sep 2011
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraureteral of Alkalinized Lidocaine as Novel Approach to Post-Ureteroscopy Pain: Double-blind Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01450566
- Acronym / sponsor ID
- Lidocaine Beiko
- Conditions
- Ureteral Calculi, Renal Calculi
- Keywords
- ureteroscopy (URS), ureteral stent placement, Ureteral Calculi, Renal Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineUse of lidocaine |
| No lidocaine | Placebo comparator | Drug: SalineNo lidocaine/standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- Solitary Kidney
- Renal failure
- Anatomic bladder or ureteral abnormality
- Uncorrected coagulopathy
- Previous cystectomy or urinary diversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineUse of lidocaine | Drug | Lidocaine |
| SalineSaline | Drug | No lidocaine |
Primary outcome
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.
1 secondary outcome
Establishment of safety of intraureteral administration of the alkalinized lidocaine solution
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Beiko, MD FRCSC principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Saline in people with Ureteral Calculi and Renal Calculi, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Robb, RN, CCRP ((613) 548 7800 ext. 3848, robbs@kgh.kari.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured by the mean VAS pain score over the study period. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.