Recruiting

Lidocaine

Sponsor:

Queen's University

Code:

NCT01450566

Conditions

Ureteral Calculi

Renal Calculi

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine

Saline

Study Details

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.

Conditions

Ureteral Calculi

Renal Calculi

Study ID

NCT01450566

Start date

Sep, 2011

Status verified date

Nov, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lidocaine

Use of lidocaine

placebo comparator: No lidocaine

No lidocaine/standard of care

Interventions

Lidocaine

Use of lidocaine

Saline

Saline

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sylvia Robb, RN, CCRP

(613) 548 7800robbs@kgh.kari.net

Joseph A Downey, MSc, CCRP

(613) 548-7832downeyj@queensu.ca

Locations

Centre for Applied Urological Research/Kingston General Hospital

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Angela Black, RN CCRP

(613) 549-6666blacka@kgh.kari.net

Joseph Downey, MSc CCRP

(613) 548-7832downeyj@queensu.ca

Principal Investigator:

Darren Beiko, MD FRCSC

More Information

Sponsor

Queen's University

Last update posted

Nov 6, 2013

Last verified

Nov, 2013

Keywords

  • ureteroscopy (URS)
  • ureteral stent placement
  • Ureteral Calculi
  • Renal Calculi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Queen's University on 2013-11-06.