Interstitial Cystitis
Conditions
Keywords
Post-operative pain management, Pain Management, Painful bladder syndrome, frequency and urgency, Dexmedetomidine, hydrodistension
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
Interventions
DRUGDexmedetomidine
1 mcg/kg/hour
DRUGNormal Saline
1mcg/kg/hr
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Dexmedetomidine: 1 mcg/kg/hour | 21 |
| Normal Saline Normal Saline: 1mcg/kg/hr | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 48.32 years STANDARD_DEVIATION 10.98 | 45.25 years STANDARD_DEVIATION 15.25 | 47 years STANDARD_DEVIATION 13.24 |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine | Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU | -1.46 units on a scale | Standard Deviation 3.33 |
| Normal Saline | Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU | -.025 units on a scale | Standard Deviation 4.88 |