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

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Status and phase: Withdrawn; Phase 3; Phase 2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

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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