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Completed

NCT Number: NCT01652183

Paracetamol for Catheter Related Bladder Discomfort

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).

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Key information

Conditions

Catheter Related Bladder Discomfort

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intravenous paracetamol

Drug

Other names: 30.11.2005-118/79

Placebo

Drug

Primary outcomes

  1. Reducing of Catheter related bladder discomfort symptoms

    Time frame: CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours

    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.

Secondary outcomes

  1. Assessment of CRBD symptoms by the evaluation of VAS, sedation scales and hemodynamic findings

    Time frame: at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours.

Sponsors and collaborators

Lead sponsor

Pinar Ergenoglu

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 27, 2012
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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