Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations
NCT ID: NCT03232021
Last Updated: 2020-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2017-08-16
2019-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group I
Administration of a placebo capsule 1 hour prior to the surgical operation
Placebo oral capsule
Placebo oral capsule administered 1 hour prior to the surgical operation
Group II
Administration of 75mg of pregabalin 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 75mg
Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation
Group III
Administration of 150mg of pregabalin 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 150 mg
Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation
Interventions
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Placebo oral capsule
Placebo oral capsule administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 75mg
Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation
Pregabalin Oral Capsule [Lyrica] 150 mg
Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* 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
45 Years
85 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Saint Savvas Anticancer Hospital
OTHER
Responsible Party
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Georgia Micha
Principal Investigator, Anesthesiologist,MD, MSc, PhD
Principal Investigators
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Sofia Poulopoulou, Head of department
Role: STUDY_DIRECTOR
Anticancer Hospital of Athens 'Saint Savvas'
Eleni Arnaoutoglou, Professor of Anesthesiology
Role: STUDY_CHAIR
University of Thessaly, Medical School, Anesthesiology Clinic
Locations
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Anticancer Hospital of Athens "Saint Savvas"
Athens, , Greece
University of Thessaly, Medical School
Volos, , Greece
Countries
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References
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Agarwal A, Dhiraaj S, Singhal V, Kapoor R, Tandon M. Comparison of efficacy of oxybutynin and tolterodine for prevention of catheter related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2006 Mar;96(3):377-80. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.
Bai Y, Wang X, Li X, Pu C, Yuan H, Tang Y, Li J, Wei Q, Han P. Management of Catheter-Related Bladder Discomfort in Patients Who Underwent Elective Surgery. J Endourol. 2015 Jun;29(6):640-9. doi: 10.1089/end.2014.0670. Epub 2014 Dec 9.
Srivastava VK, Agrawal S, Kadiyala VN, Ahmed M, Sharma S, Kumar R. The efficacy of pregabalin for prevention of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled double-blind study. J Anesth. 2015 Apr;29(2):212-6. doi: 10.1007/s00540-014-1911-x. Epub 2014 Sep 9.
Other Identifiers
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CRBD orthopedic operations
Identifier Type: -
Identifier Source: org_study_id
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