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).
Catheter Related Bladder Discomfort
Drug: intravenous paracetamol
|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|
- 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.
- 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 ]
|Study Start Date:||October 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
|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