RESPONSE TO IV LIDOCAINE PREDICT FAVORABLE RESPONSE TO ORAL MEXILETIE

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The Pilot patient was admitted and enrolled into the study 7/28/97 and discharged 7/30/97. From this pilot, some revisions took place in order to ensure a smoother running protocol. Issues that were worked on included the addition of an active placebo, as the pilot patient had no difficulty in identifying the placebo phase of the study. This double- blinded cross-over design was an improvement and was approved by the JCCI. Also, arrangements were made with the Investigational Drug Service to provide the study medications pre-mixed as to ensure the blinding of our study physician and to streamline the protocol. The Investigational Drug Service provided a block randomization schedule, as well. Four infusion patients have followed the pilot patient in participating in this study (a total of 4 prior to November, a total of 8 have been completed to date). Patients continue to be enrolled into the Post Amputation Pain Infusion Study.