NSAIDs Stent Study

Early Phase 1

Recruiting

• Conditions: Ureteral Stent Placement; Kidney Stone
• Interventions: Drug: Normal saline; Drug: Ketorolac Trometamol 30Mg/1mL Injection

• Registration Number: NCT03638999
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.

Detailed Description

Ureteral stent is routinely placed following ureteroscopic procedures to aid in urinary drainage post-operatively. Up to 80% of patients, however, experience stent-related symptoms (SRS) including lower abdominal pain, burning with urination, blood in urine and voiding symptoms affecting activities of their daily living. Intra- and/or post-operative therapeutic options are limited and most are initiated following the ureteral stent placement when the inflammatory process has already begun from ureteral manipulation, further limiting their efficacy. We, therefore, hypothesize that pre-operative intravenous administration of Ketorolac, with its anti-inflammatory and analgesic properties, will reduce the inflammatory process during ureteral manipulation and reduce SRS.

The eligible patients undergoing ureteral stent placement will be randomized 1:1 into either intervention or control group. Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml, whereas subjects in the control group will receive 1 ml of 0.9% injectable normal saline, prior to the start of the procedure. A panel of plasma inflammatory markers will be drawn and assessed pre- and post-operatively as well as at the time of stent removal as an objective measures for inflammation.

A follow-up telephone call will be made by the nursing staff on post-operative day one to check on patient status and to re-educate the patients to follow the protocol.

To assess SRS, all participants will complete the AUA Symptom Score Questionnaire and the Analog Pain Scale prior to the procedure. On post-operative day 1 and at the time of stent removal (prior to the stent being taken out), participants will complete the USSQ1 and the AUA Symptom Score. At the time of subsequent follow up visit, participants will complete the USSQ2 and AUA Symptom Score.

Study Timeline

• Study First Submitted: 2018-07-26
• Study Start: 2018-07-31
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Over 18 years of age and willing and able to provide informed consent
• Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation

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Exclusion Criteria

• Patients requiring a bilateral stone procedure.
• Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81 mg is allowed.
• Patients on any steroid therapy.
• Patients with prescription anti-inflammatory drugs.
• Patients with gastrointestinal ulcers.
• Patients with ureteral obstruction or stricture unrelated to stone disease.
• Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing).
• Patients with preexisting indwelling ureteral stent
• Patients who are pregnant or lactating.
• Patients with renal or liver impairment.
• Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group - Normal Saline	Normal saline	Subjects in the control group will receive a one-time 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.
Intervention Group - Ketorlac (NSAID)	Ketorolac Trometamol 30Mg/1mL Injection	Subjects will receive a one-time intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical/surgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion/exclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.

Primary Outcome Measures

Name	Time	Method
Analog Pain Scale, 0 - 10 rating of pain - Stent insertion Day 1	Stent insertion Day 1	The Analog Pain Scale is a patient reported scale from 0-10 that will be administered after standard surgical procedure of ureteroscopy with or without laser lithotripsy and/or stone extraction). The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Analog Pain Scale, 0 - 10 rating of pain - Stent removal	Stent removal visit (Approximately 7 to 14 days)	The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during the stent removal visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.
Analog Pain Scale, 0 - 10 rating of pain - Follow-up Visit	1 to 2 months post stent removal	The Analog Pain Scale is a patient reported scale from 0-10 that will be administered during follow up visit. The Analog Pain Scale uses 0 (zero) to describe no pain and 10 will reference worst pain.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States