¹DO, SCIREX Corporation, Austin, TX

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.