Clinical trial NCT01652183: Paracetamol for Catheter Related Bladder Discomfort
Official title: THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter Related Bladder Discomfort
Keywords: Intravenous paracetamol
catheter related bladder discomfort
urologic surgery
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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).

Primary outcomes:
measure: Reducing of Catheter related bladder discomfort symptoms
timeFrame: CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
Secondary outcomes:
measure: Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings
timeFrame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University School of Medicine Adana Teaching and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: Ergenoglu P, Akin S, Yalcin Cok O, Eker E, Kuzgunbay B, Turunc T, Aribogan A. Effect of intraoperative paracetamol on catheter-related bladder discomfort: a prospective, randomized, double-blind study. Curr Ther Res Clin Exp. 2012 Dec;73(6):186-94. doi: 10.1016/j.curtheres.2012.08.001.