Validation of a new outpatient orthopedic pain model utilizing ?Hammertoe? surgery: Statistical separation of an opioid combination and a Cox -2 inhibitor from placebo

Abstract

Background/Aims Few outpatient orthopedic pain models exist. The purpose of this study was to assess the validity of a new outpatient orthopedic pain model using Hammertoe surgery. Methods The study design was a single dose, double-blind, randomized trial assessing the effect of two marketed analgesics for acute pain after Hammertoe surgery. Subjects underwent a primary unilateral hammertoe repair requiring open partial phalangectomy with/without fixation. Upon reaching moderate or severe post-operative pain, patients were randomized to: Celecoxib 200 mg (n=29), hydrocodone/acetaminophen 10/1000 mg (n=29) or placebo (n=13). Analgesic assessments over 8 hours included: TOTPAR, SPID & SPRID and Onset. Results Results indicated excellent assay sensitivity as the model separated both compounds from placebo: TOTPAR hours 4 & 8, p<.001 & p<.02 respectively; SPID hours 4 & 8 p<.001 & p<.01 respectively; SPRID hours 4 & 8 p<.005 & p<.009 respectively. Both agents achieved median onsets of .5 hours compared to placebo (p<.002). Data collected on post-dosing days 2–6 demonstrated that the majority of patients took supplemental analgesics over this period. Conclusion This study demonstrated assay sensitivity and utility of the Hammertoe model for the study of analgesics in acute pain and its potential for multi-day, multi-dose designs. Clinical Pharmacology & Therapeutics (2005) 77, P52–P52; doi: 10.1016/j.clpt.2004.12.089