Pain, Hallux Valgus
Conditions
Brief summary
The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
Interventions
DRUGvaldecoxib
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) who required open manipulation of bone with periosteal evaluation under general anesthesia (Mayo block) * Patients with a baseline pain intensity (VAS) of greater than or equal to 45 mm * Patients with a baseline pain intensity (categorical) of moderate or severe
Exclusion criteria
* Patients scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone * Treatment with patient-controlled analgesia (PCA) subsequent to the end of anesthesia * Long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space * Use of tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, NSAIDs, and corticosteroids * Use of NSAID or analgesia after midnight the night prior to surgery or unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's Global Evaluation of Study Medication | Day 2 and Day 3 |
| Summed Pain Intensity (SPI) (categorical) through 24 hours | Day 2 and Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Time to first dose of rescue medication (rescue analgesic medication) | Days 2 to 5 |
| SPI 24 (categorical) | Day 4 and Day 5 |
| Time-specific Pain Intensity (PI) (categorical) | Days 2 to 5 |
| SPI 24 (Visual Analog Scale [VAS]) | Days 2 to 5 |
| Time-specific PI (VAS) | Days 2 to 5 |
| Patient's Global Evaluation of Study Medication | Day 4 and Day 5 |
| Health Outcomes Post-Discharge Recovery Experience | Days 2 to 5 |
| Worst Pain Intensity (derived from the Modified BPI-Short Form) | Days 2 to 5 |
| Time between doses of study medication | Days 2 to 5 |
| Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form) | Days 2 to 5 |
| Symptom Distress Questionnaire | Days 2 to 5 |
| Average Pain Intensity (derived from the Modified BPI-Short Form) | Days 2 to 5 |
| Amount of rescue medication (rescue analgesic medication) taken | Days 2 to 5 |
| Percent of patients who took rescue medication (rescue analgesic medication) | Days 2 to 5 |
| adverse events | continuous |
Countries
United States
Outcome results
None listed