Paracetamol for Catheter Related Bladder Discomfort

Catheter Related Bladder Discomfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652183
• Other study ID #: KA08/180
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2012
• Last updated: July 26, 2012
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2012
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Catheter Related Bladder Discomfort

Intervention

Drug:
• intravenous paracetamol

• Placebo

Locations

Country	Name	City	State
Turkey	Baskent University School of Medicine Adana Teaching and Research Hospital	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Pinar Ergenoglu

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No