Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pain, Post-surgical

Treatments

Drug: valdecoxib

Drug: placebo

Drug: valdecoxib/placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00653354

A3471086

VALA-0513-149

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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