Paracetamol for Catheter Related Bladder Discomfort

Phase 4

Completed

• Conditions: Catheter Related Bladder Discomfort
• Interventions: Drug: intravenous paracetamol; Drug: Placebo

• Registration Number: NCT01652183
• Lead Sponsor: Pinar Ergenoglu

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-07
• Study Completion: 2009-11
• Status Verified: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-26
• Last Update Submitted: 2012-07-26
• Study First Posted: 2012-07-27
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Paracetamol(n=32):iv 15mg/kg paracetamol	intravenous 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.
Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl	Placebo	-

Primary Outcome Measures

Name	Time	Method
Reducing of Catheter related bladder discomfort symptoms	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

Name	Time	Method
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.

Trial Locations

Locations (1)

Baskent University School of Medicine Adana Teaching and Research Hospital; 🇹🇷 Adana, Turkey