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

Pregabalin on Catheter Related Bladder Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03229668
• Other study ID #: CRBD urologic operations
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 28, 2017
• Est. completion date: February 20, 2020

Study information

• Verified date: March 2020
• Source: Saint Savvas Anticancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 20, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregabalin on Catheter Related Bladder Discomfort

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Greece	Anticancer Hospital of Athens "Saint Savvas"	Athens
Greece	University of Thessaly, Medical School	Volos

Sponsors (2)

Lead Sponsor	Collaborator
Saint Savvas Anticancer Hospital	University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (8)

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. Epub 2006 Jan 16. — View 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. Epub 2006 Mar 10. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of postsurgical catheter-related bladder discomfort after preoperative pregabalin administration	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	Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)	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
Secondary	Adverse effects of the drug	Postoperative nausea and vomiting, confusion, vertigo, blurred vision, dry mouth,sedation, dizziness	All adverse effects observed in the first 24 hours postoperatively
Secondary	Assessment of postoperative sedation	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