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Completed

NCT Number: NCT00440739

Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)

The purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after TURP.

The research hypothesis:

There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

Postoperative pain is still a significant problem for surgical patients. Conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.There are other alternatives for postoperative analgesia as NSAIDs especially COX2-inhibitors. For some specific operation such as TURP which Foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable.

Comparison(s): There is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male patient ASA physical status I-III.
  • Scheduled for an elective TURP.
  • Body weight > or = 50 kg
  • Can operate a patient-controlled analgesia (PCA) device.

Exclusion criteria

  • History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  • Known hypersensitivity to morphine.
  • History of hepatic dysfunction.
  • Creatinine clearance < 30ml/min.
  • History of bleeding tendency.
  • History of gastrointestinal bleeding or active peptic ulcer.
  • Known case of inflammatory bowel disease.
  • Patient with severe heart failure.
  • History of coronary artery disease or cerebrovascular disease.

Treatment and study plan

Etoricoxib

Drug

etoricoxib 120 mg

Other names: arcoxia

flavoxate

Drug

flavoxate 200 mg 3 times

Other names: urispas

etoricoxib, flavoxate

Drug

etoricoxib 120 mg once and flavoxate 200 mg 3 times

Other names: arcoxia, urispas

Placebo

Drug

placebo once and placebo 3 times

Primary outcomes

  1. The patients' total amount of morphine requirement in the first 24 hour.

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy: A Factorial Randomized Controlled Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 27, 2007
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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