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4-Drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans

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During the research period, recruitment has resumed after being on hold from November 2018 to May 2019. The DSMB requested that the study be placed on a temporary enrollment hold, while the study team updated the protocol to correspond to new standard of care changes within the Pittsburgh VA. Study enrollment was placed on hold for administrative reasons, there were no safety issues. Enrollment into Cohort 2 started in May of 2019, to date we have enrolled 139 patients overall including Cohorts 1 and 2. It is our hope to enroll 50 patients into Cohort 2, we currently have 41 patients enrolled in Cohort 2. Study enrollment is scheduled to end 1312020. The study continues to be regularly monitored by the University of Pittsburgh Research and Compliance Office, to date, all of the routine monitoring visits have been successful and no major issues have been identified. Team efforts continue for the management of regulatory requirements. These include i Food and Drug Administration Investigational New Drug FDA-IND annual review and approval, ii University of Pittsburgh and VA Pittsburgh Institutional Review Board IRB amendments, annual reviews, and approvals, iii University of Pittsburgh Research Conduct and Compliance Office, iv VA Pittsburgh Research and Development Quality Assurance, v University of Pittsburgh Data Safety Monitoring Board, and ultimately vi DOD Human Research Protection Office HRPO annual review and approval.

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Technical Report,30 Sep 2018,29 Sep 2019



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Approved For Public Release;

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