Paracetamol for Catheter Related Bladder Discomfort

Study Overview
=================
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).

Official Title
-----------------
THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY

Conditions
-----------------
Catheter Related Bladder Discomfort

Intervention / Treatment
-----------------
* Drug: intravenous paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl<br> | Drug: Placebo<br> <br> |
| Active Comparator: Group Paracetamol(n=32):iv 15mg/kg paracetamol<br>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<br> <br> * Other names: 30.11.2005-118/79;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing of Catheter related bladder discomfort symptoms | 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. | CRBD was evaluated at postoperatively 30th minutes, 1st, 2nd, 4th, 6th and 12th hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intravenous paracetamol, catheter related bladder discomfort, urologic surgery