Paracetamol for Catheter Related Bladder Discomfort

Sponsor

Pinar Ergenoglu (Other)

Overall Status

Completed

CT.gov ID

NCT01652183

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Catheter Related Bladder Discomfort	Drug: intravenous paracetamol Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group Control (n=32):iv 1.5 ml/kg 0.9% NaCl	Drug: Placebo
Active Comparator: Group Paracetamol(n=32):iv 15mg/kg 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.	Drug: intravenous paracetamol Other Names: 30.11.2005-118/79

Arm

Intervention/Treatment

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

Drug: Placebo

Active Comparator: Group Paracetamol(n=32):iv 15mg/kg 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.

Drug: intravenous paracetamol

Other Names:

30.11.2005-118/79

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baskent University School of Medicine Adana Teaching and Research Hospital	Adana		Turkey	01250

Sponsors and Collaborators

Pinar Ergenoglu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Pinar Ergenoglu, Baskent University School of Medicine Adana Teaching and Research Hospital, Baskent University

ClinicalTrials.gov Identifier:

NCT01652183

Other Study ID Numbers:

KA08/180

First Posted:

Jul 27, 2012

Last Update Posted:

Jul 27, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Pinar Ergenoglu, Baskent University School of Medicine Adana Teaching and Research Hospital, Baskent University

Intravenous paracetamol

catheter related bladder discomfort

urologic surgery

Additional relevant MeSH terms:

Acetaminophen

Study Results

No Results Posted as of Jul 27, 2012