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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: etoricoxib; Drug: placebo; Drug: flavoxate; Drug: etoricoxib, flavoxate

Study type: Interventional

Funder types: Other

Identifiers

NCT00440739

SiEc 161/2548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

1=placebo

Treatment:

Drug: placebo

2

Active Comparator group

Description:

2= etoricoxib

Treatment:

Drug: etoricoxib

3

Active Comparator group

Description:

3=falvoxate

Treatment:

Drug: flavoxate

4

Active Comparator group

Description:

etoricoxib and flavoxate

Treatment:

Drug: etoricoxib, flavoxate