Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations

Conditions
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Pregabalin on Catheter Related Bladder Discomfort

Intervention / Treatment
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* Drug: Placebo oral capsule
* Drug: Pregabalin Oral Capsule [Lyrica] 75mg
* Drug: Pregabalin Oral Capsule [Lyrica] 150 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, double-blind,randomized, placebo controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I<br>Administration of a placebo capsule 1 hour prior to the surgical operation | Drug: Placebo oral capsule<br>* Placebo oral capsule administered 1 hour prior to the surgical operation<br>|
| Experimental: Group II<br>Administration of 75mg of pregabalin 1 hour prior to the surgical operation | Drug: Pregabalin Oral Capsule [Lyrica] 75mg<br>* Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation<br>* Other names: Pregabalin;|
| Experimental: Group III<br>Administration of 150mg of pregabalin 1 hour prior to the surgical operation | Drug: Pregabalin Oral Capsule [Lyrica] 150 mg<br>* Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation<br>* Other names: Pregabalin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration | 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) | Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale) | 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 | Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively | 
| Adverse effects of the drug | Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness | All adverse effects observed in the first 24 hours postoperatively | 
| Assessment of postoperative sedation | 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) | In the operating theatre immediately after patient's extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary bladder, urinary catheters, pregabalin