Clinical trial NCT03232021: Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations
Official title: Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pregabalin on Catheter Related Bladder Discomfort
Keywords: urinary bladder
urinary catheters
pregabalin
Lead sponsor: Saint Savvas Anticancer Hospital
Sponsor class: OTHER
Collaborators: name: University of Thessaly
First posted: 2017-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind,randomized, placebo controlled trial
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration
timeFrame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
Secondary outcomes:
measure: Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)
timeFrame: Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively
measure: Adverse effects of the drug
timeFrame: All adverse effects observed in the first 24 hours postoperatively
measure: Assessment of postoperative sedation
timeFrame: In the operating theatre immediately after patient's extubation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Anticancer Hospital of Athens "Saint Savvas"
city: Vólos
country: Greece
facility: University of Thessaly, Medical School
Study officials:
affiliation: Anticancer Hospital of Athens 'Saint Savvas'
name: Sofia Poulopoulou, Head of department
role: STUDY_DIRECTOR
affiliation: University of Thessaly, Medical School, Anesthesiology Clinic
name: Eleni Arnaoutoglou, Professor of Anesthesiology
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.