Catheter Analgesia Trial - Full Text View

Sponsored by:	Loyola University
Information provided by:	Loyola University
ClinicalTrials.gov Identifier:	NCT00771173

Purpose

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.

The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups.

Condition	Intervention	Phase
Interstitial Cystitis	Drug: phenazopyridine HCl Other: Placebo	Phase IV

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Phenazopyridine Phenazopyridine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project

Further study details as provided by Loyola University:

Primary Outcome Measures:

Reduction of catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 Phenazopyrdine HCl 200 mg q8h x 24
2: Placebo Comparator 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 Placebo tablet administered q8 hours for 24 hours postop.

Arms

Assigned Interventions

1: Active Comparator

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

Phenazopyrdine HCl 200 mg q8h x 24

2: Placebo Comparator

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

Placebo tablet administered q8 hours for 24 hours postop.

Detailed Description:

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 measurments.

The secondary aim is to compare overall post operative pain medication requirements, including cumulative dose and patterns of medication utilization between groups.

The tertiary aim is to determine whether blinding is feasible in such a clinical trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771173

Contacts

Contact: Lisa Guilfoyle

708-219-4657

lguilfo@lumc.edu

Locations

United States, Illinois
Loyola Univeristy Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Elaine Fluder, MSN
Sub-Investigator: Charles Anderson, MD
Sub-Investigator: Maryann Chimhanda, MD
Sub-Investigator: Jayme Sloan, MD
Sub-Investigator: Suzanne Galloway, MD
Sub-Investigator: James Sinacore, PhD

Sponsors and Collaborators

Loyola University

Investigators

Principal Investigator:

Linda Brubaker, MD

Loyola University

More Information

Responsible Party:	Loyola University Chicago, Stritch School of Medicine ( Linda Brubaker )
Study ID Numbers:	201073
Study First Received:	October 9, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00771173
Health Authority:	United States: Institutional Review Board

Keywords provided by Loyola University:

Phenazopyrdine
post operative bladder catheritization
VAS scores
Bladder pain related to indwelling foley catheters.
Bladder irritaion related to indwelling foley catheters.

Study placed in the following topic categories:

Cystitis, Interstitial
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Cystitis
Pain

ClinicalTrials.gov processed this record on January 16, 2009