Paracetamol for Catheter Related Bladder Discomfort

Pinar Ergenoglu

Status and phase: Completed; Phase 4

Conditions: Catheter Related Bladder Discomfort

Treatments: Drug: Placebo; Drug: intravenous paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT01652183

KA08/180

Details and patient eligibility

About

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).

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl

Placebo Comparator group

Treatment:

Drug: Placebo

Group Paracetamol(n=32):iv 15mg/kg paracetamol

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous paracetamol