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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: placebo; Drug: etoricoxib; Drug: flavoxate; Drug: etoricoxib, flavoxate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; 1=placebo	Drug: placebo; placebo once and placebo 3 times
Active Comparator: 2; 2= etoricoxib	Drug: etoricoxib; etoricoxib 120 mg; Other Names: arcoxia
Active Comparator: 3; 3=falvoxate	Drug: flavoxate; flavoxate 200 mg 3 times; Other Names: urispas
Active Comparator: 4; etoricoxib and flavoxate	Drug: etoricoxib, flavoxate; etoricoxib 120 mg once and flavoxate 200 mg 3 times; Other Names: arcoxia; urispas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The patients' total amount of morphine requirement in the first 24 hour.	24 hour

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Sirilak Suksompong, MD, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 2, 2006
• First Submitted That Met QC Criteria: February 26, 2007
• First Posted (Estimate): February 27, 2007

Study Record Updates

• Last Update Posted (Estimate): February 5, 2009
• Last Update Submitted That Met QC Criteria: February 4, 2009
• Last Verified: February 1, 2007

More Information

Terms related to this study

• Keywords: postoperative pain, etoticoxib, etoricoxib; Pain relief after transurethral resection of prostate.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Urological Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib; Flavoxate
• Other Study ID Numbers: SiEc 161/2548

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No