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

Phase 4

Completed

• Conditions: Interstitial Cystitis
• Interventions: Drug: Normal Saline; Drug: Dexmedetomidine

• Registration Number: NCT01195116
• Lead Sponsor: University of Rochester

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-03
• Results First Submitted: 2015-03-12
• Results First Submitted QC: 2015-03-12
• Results First Posted: 2015-03-24
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	-
Dexmedetomidine	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU	Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average	It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States