NCT03229668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 28, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

July 18, 2017

Last Update Submit

March 28, 2020

Conditions

Pregabalin on Catheter Related Bladder Discomfort

Keywords

urinary bladderurinary catheterspregabalin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Postoperative pain assessed by NPRS scale (Numeric Pain Rating Scale)

    Total amount of analgesics in morphine analogues administered in the first 24 hours postoperatively

  • Adverse effects of the drug

    All adverse effects observed in the first 24 hours postoperatively

  • Assessment of postoperative sedation

    In the operating theatre immediately after patient's extubation

Study Arms (3)

Group I

PLACEBO COMPARATOR

Administration of a placebo capsule 1 hour prior to the surgical operation

Drug: Placebo oral capsule

Group II

EXPERIMENTAL

Administration of 75mg of pregabalin 1 hour prior to the surgical operation

Drug: Pregabalin Oral Capsule [Lyrica] 75mg

Group III

EXPERIMENTAL

Administration of 150mg of pregabalin 1 hour prior to the surgical operation

Drug: Pregabalin Oral Capsule [Lyrica] 150 mg

Interventions

Placebo oral capsuleDRUG

Placebo oral capsule administered 1 hour prior to the surgical operation

Group I
Pregabalin Oral Capsule [Lyrica] 75mgDRUG

Pregabalin Oral Capsule \[Lyrica\] 75 mg administered 1 hour prior to the surgical operation

Also known as: Pregabalin
Group II
Pregabalin Oral Capsule [Lyrica] 150 mgDRUG

Pregabalin Oral Capsule \[Lyrica\] 150 mg administered 1 hour prior to the surgical operation

Also known as: Pregabalin
Group III

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients about to be subjected to urinary operations
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anticancer Hospital of Athens "Saint Savvas"

Athens, 115 22, Greece

Location

University of Thessaly, Medical School

Volos, 38221, Greece

Location

Related 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. doi: 10.1093/bja/ael003. Epub 2006 Jan 16.

    PMID: 16415311BACKGROUND

  • 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.

    PMID: 25200037BACKGROUND

  • 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.

    PMID: 22749555BACKGROUND

  • 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.

    PMID: 25335575BACKGROUND

  • 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.

    PMID: 23869107BACKGROUND

  • 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.

    PMID: 16531445BACKGROUND

  • 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.

    PMID: 18653496BACKGROUND

  • 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.

    PMID: 25304838BACKGROUND

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Eleni Arnaoutoglou, Prof Of Anesthesiology

    University of Thessaly, Medical School, Anesthesiology Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective, double-blind,randomized, placebo controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist,MD, MSc, PhD

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 25, 2017

Study Start

July 28, 2017

Primary Completion

December 31, 2019

Study Completion

February 20, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

GR(2)