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Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Normal Saline
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Post-operative pain management, Pain Management, Painful bladder syndrome, frequency and urgency, Dexmedetomidine, hydrodistension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications.
  • 2. Gender of Patients: Male & female,Age of Patients: 18 and older

Exclusion Criteria:

  • Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine

Normal Saline

Arm Description

Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.

Outcomes

Primary Outcome Measures

Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2010
Last Updated
March 25, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01195116
Brief Title
Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
Official Title
Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effects of dexmedetomidine while patients undergo treatment for Interstitial Cystitis (IC). The investigators goal is to demonstrate in patients with IC undergoing bladder hydrodistension that the use of dexmedetomidine as a supplemental anesthetic agent will result in better postoperative pain management.
Detailed Description
Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications. Data collected will include: I. Postoperative Outcomes i. Pain Reported (Visual Analogue Scale) ii. Post-operative opiate use iii. Time in PACU iv. Time until discharge v. Adverse Events (i.e. nausea/vomiting, nursing intervention) II. Intermediate-term Outcomes (4-6 weeks) i. Interstitial Cystitis Symptom & Problem Index ii. Revised McGill Pain Score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Post-operative pain management, Pain Management, Painful bladder syndrome, frequency and urgency, Dexmedetomidine, hydrodistension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
1 mcg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Sodium Chloride
Intervention Description
1mcg/kg/hr
Primary Outcome Measure Information:
Title
Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU
Description
It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.
Time Frame
Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a clinical diagnosis of IC scheduled for cystoscopy and hydrodistension for both diagnostic and therapeutic indications. 2. Gender of Patients: Male & female,Age of Patients: 18 and older Exclusion Criteria: Conduction disturbance (second degree AV block or greater), or previous reaction to medications used in this study. Patients receiving spinal anesthesia will not be included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Karan, MD
Organizational Affiliation
University of Rochester Department of Affiliation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Mayer, MD
Organizational Affiliation
University of Rochester Department of Urology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denham Ward, MD, PhD
Organizational Affiliation
University of Rochester Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

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