NCT01652183|CompletedPhase 4DMC
Paracetamol for Catheter Related Bladder Discomfort
THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY
Loading search results
Sponsor study identifier
interventional
64
1 country
1
Study Start
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
November 2009
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 2009
Actual (reported)November 2009
Actual (reported)July 25, 2012
Actual (reported)July 27, 2012
Actual (reported)Reducing of Catheter related bladder discomfort symptoms
CRBD was evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses) at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours
Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings
at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.
The patients were randomly divided into two groups: Group P (Paracetamol group, n=32) received intravenous 15mg/kg paracetamol during the surgery and Group C (Control Group, n=32) received intravenous 1.5 ml/kg 0.9% NaCl solution 30 minutes before the of surgery.At the end of the surgery, all patients had an nephrostomy catheter and the insertion site was infiltrated with 20 ml 0.25% bupivacaine infiltration for postoperative analgesia. Each patient received patient-controlled intravenous analgesia by meperidine (10 mg bolus, 20-minute lock-out, no infusion dose and 4 hour limit) for postoperative analgesia. All patients were planned to receive tenoxicam 20 mg intravenously as a rescue analgesic when visual analogue scale (VAS) was \>3.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, 01250, Turkey (Türkiye)
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.
64 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2012
First Posted
July 27, 2012
Study Start
October 2008
Date type not reportedContact the study team to confirm eligibility.
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.
This date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
July 27, 2012
Record last verified: 2012-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: