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

March 28, 2020 updated by: Georgia Micha, Saint Savvas Anticancer Hospital
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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 115 22
        • Anticancer Hospital of Athens "Saint Savvas"
      • Vólos, Greece, 38221
        • University of Thessaly, Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group I
Administration of a placebo capsule 1 hour prior to the surgical operation
Drug: Placebo oral capsule
Placebo oral capsule administered 1 hour prior to the surgical operation
Experimental: Group II
Administration of 75mg of pregabalin 1 hour prior to the surgical operation
Drug: Pregabalin Oral Capsule [Lyrica] 75mg
Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation
Other Names:
  • Pregabalin
Experimental: Group III
Administration of 150mg of pregabalin 1 hour prior to the surgical operation
Drug: Pregabalin Oral Capsule [Lyrica] 150 mg
Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation
Other Names:
  • Pregabalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
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
Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively
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
All adverse effects observed in the first 24 hours postoperatively
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)
In the operating theatre immediately after patient's extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Savvas Anticancer Hospital

Collaborators

University of Thessaly

Investigators

  • Study Director: Sofia Poulopoulou, Head of department, Anticancer Hospital of Athens 'Saint Savvas'
  • Study Chair: Eleni Arnaoutoglou, Professor of Anesthesiology, University of Thessaly, Medical School, Anesthesiology Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

April 30, 2019

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRBD orthopedic operations

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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