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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>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. | Drug: Dexmedetomidine<br>* 1 mcg/kg/hour<br>* Other names: Precedex;|
| Placebo Comparator: Normal Saline<br> | Drug: Normal Saline<br>* 1mcg/kg/hr<br>* Other names: Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative pain management, Pain Management, Painful bladder syndrome, frequency and urgency, Dexmedetomidine, hydrodistension