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

Phase 3WithdrawnNCT03232021

Saint Savvas Anticancer Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Pregabalin on Catheter Related Bladder Discomfort

Interventions

Placebo oral capsuleDRUG

Placebo oral capsule administered 1 hour prior to the surgical operation

Pregabalin Oral Capsule [Lyrica] 75mgDRUG

Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation

Pregabalin Oral Capsule [Lyrica] 150 mgDRUG

Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Anticancer Hospital of Athens "Saint Savvas"

Athens, Greece

University of Thessaly, Medical School

Volos, Greece

Outcomes

Primary Outcomes

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)

Time frame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: In the operating theatre immediately after patient's extubation

Data from ClinicalTrials.gov

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