Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
- Conditions
- Pregabalin on Catheter Related Bladder Discomfort
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03229668
- Lead Sponsor
- Saint Savvas Anticancer Hospital
- 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 urological operations because of the high incidence of CRBD observed in this kind of surgical population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- All patients about to be subjected to urinary operations
- Signed informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I Placebo oral capsule Administration of a placebo capsule 1 hour prior to the surgical operation Group II Pregabalin Oral Capsule [Lyrica] 75mg Administration of 75mg of pregabalin 1 hour prior to the surgical operation Group III Pregabalin Oral Capsule [Lyrica] 150 mg Administration of 150mg of pregabalin 1 hour prior to the surgical operation
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
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
Trial Locations
- Locations (2)
Anticancer Hospital of Athens "Saint Savvas"
🇬🇷Athens, Greece
University of Thessaly, Medical School
🇬🇷Volos, Greece