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Parecoxib for Treatment of Catheter Related Bladder Discomfort

Sponsor
University Tunis El Manar (Other)
Overall Status
Completed
CT.gov ID
NCT02729935
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
3
Duration (Months)
19.9
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Mar 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

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 Names:
  • DYNASTAT

    		•
    Placebo Comparator: Placebo

    An equal volume of saline

    Drug: Placebo
    An equal volume of saline
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reducing of Catheter related bladder discomfort symptoms [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 [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 [During the first 24 hours]

      Blood loss, length of hospitalization, renal function and postoperative cardiovascular (CV) events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ali JENDOUBI Tunis Tunisia 1006

    Sponsors and Collaborators

    • University Tunis El Manar

    Investigators

    • Principal Investigator: Ali JENDOUBI, University Tunis El Manar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Apr 6, 2016
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ali JENDOUBI, MD, Assistant Professor, University Tunis El Manar
    Parecoxib
    Bladder Discomfort
    Additional relevant MeSH terms:
    Pain, Postoperative
    Parecoxib

    Study Results

    No Results Posted as of Oct 18, 2016