Paracetamol for Catheter Related Bladder Discomfort

NCT01652183 | Completed Phase 4 DMC

• 1 other identifier: KA08/180
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Catheter Related Bladder Discomfort

Keywords

Intravenous paracetamol; catheter related bladder discomfort; urologic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

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

PLACEBO COMPARATOR

Drug: Placebo

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

ACTIVE COMPARATOR

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

Interventions

intravenous paracetamol DRUG

Also known as: 30.11.2005-118/79

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

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age,
• American Society of Anesthesiologists (ASA) Physical Status of I-II,
• undergoing PNL with urinary bladder catheter.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pinar Ergenoglu: lead

Study Sites (1)

Baskent University School of Medicine Adana Teaching and Research Hospital

Adana, 01250, Turkey (Türkiye)

Location

Related Publications (3)

• Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.

  PMID: 18653496 BACKGROUND

• Binhas M, Motamed C, Hawajri N, Yiou R, Marty J. Predictors of catheter-related bladder discomfort in the post-anaesthesia care unit. Ann Fr Anesth Reanim. 2011 Feb;30(2):122-5. doi: 10.1016/j.annfar.2010.12.009. Epub 2011 Jan 31.

  PMID: 21277735 BACKGROUND

• Ergenoglu P, Akin S, Yalcin Cok O, Eker E, Kuzgunbay B, Turunc T, Aribogan A. Effect of intraoperative paracetamol on catheter-related bladder discomfort: a prospective, randomized, double-blind study. Curr Ther Res Clin Exp. 2012 Dec;73(6):186-94. doi: 10.1016/j.curtheres.2012.08.001.

  PMID: 24653520 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Baskent University School of Medicine Adana Teaching and Research Hospital

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

TU (1)