Pain, Post-surgical
Conditions
Keywords
hallux valgus
Brief summary
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
Interventions
DRUGvaldecoxib
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
DRUGplacebo
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
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) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block) * Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS
Exclusion criteria
* Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone * Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia * Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space * Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24) | Day 1 |
| Total Pain Relief through 24 hours (TOTPAR 24) | Day 1 |
| Patient's Global Evaluation of Study Medication | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| time-specific PID (VAS) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours |
| Summed Pain Intensity (SPID)24 (VAS) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours |
| time between doses of study medication | Day 1 |
| percent of patients who took rescue medication | Day 1 |
| Patient's Satisfaction Questionnaire | Day 1 |
| time to rescue medication | 2, 4, 6, 8, 10, 12, 16, and 24 hours |
| Time-specific Pain Intensity Difference (PID) (categorical) | 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours |
| time-specific pain relief | 2, 4, 6, 8, 10, 12, 16, and 24 hours |
Countries
United States
Outcome results
None listed