Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Analgesics; Valdecoxib

Criteria

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