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Paracetamol for Catheter Related Bladder Discomfort

Information source: Baskent University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Catheter Related Bladder Discomfort

Intervention: intravenous paracetamol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pinar Ergenoglu

Summary

The insertion of an urinary catheter in a patient undergoing a surgical procedure, especially in urinary interventions, may lead to catheter-related bladder discomfort with varying degrees of severity during the postoperative period. Catheter-related bladder discomfort (CRBD) symptoms associated with indwelling urinary catheter are similar to overactive bladder symptoms such as discomfort in the suprapubic region, urinary urgency, frequency, burning sensation with or without urge incontinence. Paracetamol is a drug with proven efficiency for the management of mild and moderate postoperative pain. In this study, the investigators hypothesized to address the effect of single-dose intravenous paracetamol on postoperative CRBD following percutaneous nephrolithotomy surgery (PNL).

Clinical Details

Official title: THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reducing of Catheter related bladder discomfort symptoms

Secondary outcome: Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- ≥ 18 years of age,

- American Society of Anesthesiologists (ASA) Physical Status of I-II,

- undergoing PNL with urinary bladder catheter.

Exclusion Criteria:

- obesity (BMI > 30),

- chronic opioid use,

- bladder outflow obstruction,

- benign prostatic hyperplasia, and

- overactive bladder (OAB) (frequency > 3 times at night or > 8 times within 24h).

Locations and Contacts

Baskent University School of Medicine Adana Teaching and Research Hospital, Adana 01250, Turkey
Additional Information

Related publications:

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.

Binhas M, Motamed C, Hawajri N, Yiou R, Marty J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann Fr Anesth Reanim. 2011 Feb;30(2):122-5. doi: 10.1016/j.annfar.2010.12.009. Epub 2011 Jan 31.

Starting date: October 2008
Last updated: July 26, 2012

Page last updated: August 23, 2015

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