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Completed

NCT Number: NCT03229668

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

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.

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Key information

Conditions

Pregabalin on Catheter Related Bladder Discomfort

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anticancer Hospital of Athens "Saint Savvas", Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oral capsule

Drug

Placebo oral capsule administered 1 hour prior to the surgical operation

Pregabalin Oral Capsule [Lyrica] 75mg

Drug

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

Other names: Pregabalin

Pregabalin Oral Capsule [Lyrica] 150 mg

Drug

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

Other names: Pregabalin

Primary outcomes

  1. Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration

    Time frame: 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 outcomes

  1. Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)

    Time frame: 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

  2. Adverse effects of the drug

    Time frame: All adverse effects observed in the first 24 hours postoperatively

    Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness

  3. Assessment of postoperative sedation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Saint Savvas Anticancer Hospital

Other

Collaborators

  • University of Thessaly

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 25, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.