CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial

Study Overview
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Brief Summary
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The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.

Detailed Description
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This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery. Hypothesis and Aims: We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a Foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo. The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurements.

Official Title
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THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project

Conditions
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Catheter-related Bladder Discomfort

Intervention / Treatment
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* Drug: phenazopyridine HCl
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication. Exclusion Criteria: Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products). Known contraindications to phenazopyridine HCl: Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease). History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs). Known glucose-6-phosphate dehydrogenase deficiency. Simultaneous suprapubic catheterization. Inability to take oral medication within 12 hours after surgery. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study Medication Group<br>Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first | Drug: phenazopyridine HCl<br>* Phenazopyrdine HCl 200 mg q8h x 24<br>* Other names: Pyridium;|
| Placebo Comparator: Placebo tablet Group<br>For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. | Other: Placebo<br>* Placebo tablet administered q8 hours for 24 hours postop.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenazopyrdine, post operative bladder catheritization, VAS scores, Bladder pain related to indwelling foley catheters., Bladder irritaion related to indwelling foley catheters.