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
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