Clinical trial NCT03229668: Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
Official title: Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2017-07-25
Enrollment: 78
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 urological operations because of the high incidence of CRBD observed in this kind of surgical population.


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: Volos
country: Greece
facility: University of Thessaly, Medical School
Study officials:
affiliation: University of Thessaly, Medical School, Anesthesiology Clinic
name: Eleni Arnaoutoglou, Prof 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: 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.
citation: Tauzin-Fin P, Stecken L, Sztark F. [Catheter-related bladder discomfort in post-anaesthesia care unit]. Ann Fr Anesth Reanim. 2012 Jul-Aug;31(7-8):605-8. doi: 10.1016/j.annfar.2012.03.009. Epub 2012 Jun 29. French.
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: Ryu JH, Hwang JW, Lee JW, Seo JH, Park HP, Oh AY, Jeon YT, Do SH. Efficacy of butylscopolamine for the treatment of catheter-related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study. Br J Anaesth. 2013 Dec;111(6):932-7. doi: 10.1093/bja/aet249. Epub 2013 Jul 17.
citation: Agarwal A, Gupta D, Kumar M, Dhiraaj S, Tandon M, Singh PK. Ketamine for treatment of catheter related bladder discomfort: a prospective, randomized, placebo controlled and double blind study. Br J Anaesth. 2006 May;96(5):587-9. doi: 10.1093/bja/ael048. Epub 2006 Mar 10.
citation: Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.
citation: Nam K, Seo JH, Ryu JH, Oh AY, Lee T, Park HP, Jeon YT, Hwang JW. Randomized, clinical trial on the preventive effects of butylscopolamine on early postoperative catheter-related bladder discomfort. Surgery. 2015 Feb;157(2):396-401. doi: 10.1016/j.surg.2014.05.017. Epub 2014 Oct 8.