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Parecoxib for Treatment of Catheter Related Bladder Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729935
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Ali JENDOUBI, University Tunis El Manar

Brief Summary:
Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Parecoxib Drug: Placebo Phase 4

Detailed Description:

Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.

Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Tolerance of Parecoxib for Prevention of Catheter-related Bladder Discomfort in Patients Undergoing Catheterization After TURBT: A Prospective, Randomized, Placebo-controlled, Double-blind Study
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Parecoxib
40 mg of intravenous parecoxib (DYNASTAT )30 min before surgery
Drug: Parecoxib
40 mg of intravenous parecoxib 30 min before surgery
Other Name: DYNASTAT

Placebo Comparator: Placebo
An equal volume of saline
Drug: Placebo
An equal volume of saline
Other Name: Saline




Primary Outcome Measures :
  1. Reducing of Catheter related bladder discomfort symptoms [ Time Frame: 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 :
  1. Severity of Pain at suprapubic area [ Time Frame: at postoperative 0, 1, 6 and 12 hours ]
    Assessed by Visual Analogue Scale (VAS) and rescue analgesia requirement ( Paracetamol or nefopam)

  2. safety and tolerability of parecoxib [ Time Frame: During the first 24 hours ]
    Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (>/=18)
  2. Male or female
  3. Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
  4. Under spinal anesthesia
  5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

  1. Patient who disagrees to participate this investigation
  2. Patient with severe cardiovascular disease
  3. Patient with small-sized foley catheter (less than 18 Fr.)
  4. Patinets with bladder outflow obstruction
  5. Patient with overactive bladder (frequency >3 times,in the night or >8 times in 24 h)
  6. Patients with chronic renal failure
  7. Patient with morbid obesity
  8. Patient with medications for chronic pain
  9. Patient with disturbance of the central nervous system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729935


Locations
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Tunisia
Ali JENDOUBI
Tunis, Tunisia, 1006
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Principal Investigator: Ali JENDOUBI University Tunis El Manar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ali JENDOUBI, MD, Assistant Professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT02729935    
Other Study ID Numbers: University Of Tunis El Manar
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ali JENDOUBI, University Tunis El Manar:
Parecoxib
Bladder Discomfort
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Parecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents