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Paracetamol for Catheter Related Bladder Discomfort

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ClinicalTrials.gov Identifier: NCT01652183
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Pinar Ergenoglu, Baskent University

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).

Condition or disease Intervention/treatment Phase
Catheter Related Bladder Discomfort Drug: intravenous paracetamol Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY
Study Start Date : October 2008
Primary Completion Date : July 2009
Study Completion Date : November 2009

Arm Intervention/treatment
Placebo Comparator: Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl Drug: Placebo
Active Comparator: Group Paracetamol(n=32):iv 15mg/kg paracetamol
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.
Drug: intravenous paracetamol
Other Name: 30.11.2005-118/79



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652183


Locations
Turkey
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, Turkey, 01250
Sponsors and Collaborators
Pinar Ergenoglu

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pinar Ergenoglu, Baskent University School of Medicine Adana Teaching and Research Hospital, Baskent University
ClinicalTrials.gov Identifier: NCT01652183     History of Changes
Other Study ID Numbers: KA08/180
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Pinar Ergenoglu, Baskent University:
Intravenous paracetamol
catheter related bladder discomfort
urologic surgery

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics