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

NCT03232021 | Withdrawn Phase 2

• 1 other identifier: CRBD orthopedic operations
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregabalin on Catheter Related Bladder Discomfort

Keywords

urinary bladder; urinary catheters; pregabalin

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 capsule DRUG

Placebo oral capsule administered 1 hour prior to the surgical operation

Group I

Pregabalin Oral Capsule [Lyrica] 75mg DRUG

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 mg DRUG

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

Also known as: Pregabalin

Group III

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Saint Savvas Anticancer Hospital: lead
• University of Thessaly: collaborator

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 (3)

• 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: 16415311 BACKGROUND

• 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: 25335575 BACKGROUND

• 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: 25200037 BACKGROUND

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sofia Poulopoulou, Head of department

  Anticancer Hospital of Athens 'Saint Savvas'

  STUDY DIRECTOR

• Eleni Arnaoutoglou, Professor 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist,MD, MSc, PhD

Model Details: Prospective, double-blind,randomized, placebo controlled trial

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: August 16, 2017
• Primary Completion: December 31, 2018
• Study Completion: April 30, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

GR (2)