Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery (NCT00653354) | Clinical Trial Compass
CompletedPhase 3
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
United States360 participantsStarted 2002-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)