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

S

Saint Savvas Anticancer Hospital

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

Pregabalin on Catheter Related Bladder Discomfort

Treatments

Drug: Placebo oral capsule
Drug: Pregabalin Oral Capsule [Lyrica] 150 mg
Drug: Pregabalin Oral Capsule [Lyrica] 75mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03232021
CRBD orthopedic operations

Details and patient eligibility

About

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.

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 3 patient groups, including a placebo group

Group I
Placebo Comparator group
Description:
Administration of a placebo capsule 1 hour prior to the surgical operation
Treatment:
Drug: Placebo oral capsule
Group II
Experimental group
Description:
Administration of 75mg of pregabalin 1 hour prior to the surgical operation
Treatment:
Drug: Pregabalin Oral Capsule [Lyrica] 75mg
Group III
Experimental group
Description:
Administration of 150mg of pregabalin 1 hour prior to the surgical operation
Treatment:
Drug: Pregabalin Oral Capsule [Lyrica] 150 mg

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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