Bunionectomy, Orthopedic Surgery
Conditions
Brief summary
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.
Interventions
Sponsors
POZEN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic. * Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications. * Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.
Exclusion criteria
* Subjects who are pregnant. * Subjects who have significant obesity. * Subjects with medically significant heart, liver, kidney, lung or endocrine disease. * Subjects with active viral disease, i.e. hepatitis, HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy) | — |
| To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo. | — |
Countries
United States
Outcome results
None listed