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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Hallux Valgus

Pain

Treatments

Drug: valdecoxib/placebo

Drug: valdecoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00683137

VALA-0513-144

A3471084

Details and patient eligibility

About

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.

Enrollment

450 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) 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