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Paracetamol for Catheter Related Bladder Discomfort

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pinar Ergenoglu, Baskent University
ClinicalTrials.gov Identifier:
NCT01652183
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Catheter Related Bladder Discomfort
 Drug: intravenous paracetamol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baskent University:

Primary Outcome Measures:
  • Reducing of Catheter related bladder discomfort symptoms [ Time Frame: CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652183

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

Publications:

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
Study First Received: July 25, 2012
Last Updated: July 26, 2012
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 19, 2013