Pregabalin on Catheter Related Bladder Discomfort
Conditions
Keywords
urinary bladder, urinary catheters, pregabalin
Brief summary
The aim of this study is to assess the effect of pregabalin administration on catheter-related bladder discomfort (CRBD). The study group includes patients that are about to be subjected to orthopedic operations.
Interventions
DRUGPlacebo oral capsule
Placebo oral capsule administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation
Sponsors
University of Thessaly
Saint Savvas Anticancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective, double-blind,randomized, placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All patients about to be subjected to urinary operations * Signed informed consent
Exclusion criteria
* Preoperative urinary bladder/kidney dysfunction as a result of spinal cord pathology * History of overactive ((urinary frequency\>3 times at night and \>8 times in 24 hours), neurogenic bladder * End stage renal failure * Central nervous system dysfunction * Mental illness/ substance abuse * Sensitivity to pregabalin * Preoperative administration of pregabalin for other indications * Recent bladder catheterization \<3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration | Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively | Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale) | Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively | The goal is to achieve pain scores\<3 as these are assessed by the NPRS scale. In order to achieve that we will record the total amount of milligrams of analogues of morphine administered in the first 24 hours postoperatively |
| Adverse effects of the drug | All adverse effects observed in the first 24 hours postoperatively | Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness |
| Assessment of postoperative sedation | In the operating theatre immediately after patient's extubation | The Ramsay Sedation Scale is used to measure different levels of sedation in medical patients (1=Patient is anxious and agitated or restless, or both 2=Patient is co-operative, oriented, and tranquil, 3=Patient responds to commands only, 4=Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5=Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6=Patient exhibits no response) |
Countries
Greece
Outcome results
None listed