Catheter Related Bladder Discomfort
Conditions
Keywords
Intravenous paracetamol, catheter related bladder discomfort, urologic surgery
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).
Interventions
DRUGPlacebo
Sponsors
Pinar Ergenoglu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed