OTA/Pacira Directed Topic Proposal Research Grant Application Short Instructions Funding Cycle June 1, 2017- December 31, 2018 Application deadline: January 9, 2017 The OTA is accepting grant proposals to test the following hypothesis: Fracture patients treated with EXPAREL vs. the standard of care will “Hip have better outcomes” In order to test the hypothesis the following research aspects need to be studied: Patient population: Sixty-five years of age and older, suffering intra- or extra-capsular hip fractures undergoing ORIF or arthroplasty will be randomized into an EXPAREL group or the standard treatment group. Cohort group: Numbers should be approximately 25 in each arm of the study. Standardized Technique: For use of EXPAREL the following guidelines have been provided by Medical Affairs, Pacira Pharmaceuticals to assure proper volume expansion and infiltration into the surgical site. The following techniques was developed by Tony Sanzone MD and Hank Hutchinson MD (EXPAREL PROTOCOL below). It is recommended that Medical Affairs be allowed to work with physicians in the study to assure proper technique and volume as EXPAREL is highly dependent on correct volume and technique into the surgical site, analysis should also look at age stratification. (Note: EXPAREL will not be provided by Pacira). Successful proposals will outline a program that achieves the following: Patient recruitment will be completed within a 15-month period from the time of funding. Multicenter studies are strongly encouraged to achieve this goal. No-cost extensions will be granted. Successful research proposals must outline a clear plan that demonstrates infrastructure is in place to achieve patient recruitment in the designated time period. Inclusion criteria: Patient sixty-five years of age and older, with isolated intra- or extra-capsular hip fractures undergoing ORIF (including intramedullary nailing) or arthroplasty Able to consent to the study Exclusion criteria: Pre-existing dementia Unable to consent to the study Patients undergoing closed reduction and percutaneous pinning of femoral neck fractures The following are suggested for primary outcomes: Delirium Scale (CAM) Total morphine equiv. post-surgery VAS pain scores Time to ambulate with physical therapy Secondary clinical measures: LOS Discharge Disposition (home vs. skilled nursing vs. inpatient rehab) 30 day readmission rates Any adverse event (AE) that leads to ICU admission or operation
OTA/Pacira Directed Topic Proposal Research Grant Application Short Instructions Funding Cycle June 1, 2017- December 31, 2018 Application deadline: January 9, 2017 The OTA is accepting grant proposals to test the following hypothesis: “Hip Fracture patients treated with EXPAREL vs. the standard of care will have better outcomes” In order to test the hypothesis the following research aspects need to be studied: Patient population: Sixty-five years of age and older, suffering intra- or extra-capsular hip fractures undergoing ORIF or arthroplasty will be randomized into an EXPAREL group or the standard treatment group. Cohort group: Numbers should be approximately 25 in each arm of the study. Standardized Technique: For use of EXPAREL the following guidelines have been provided by Medical Affairs, Pacira Pharmaceuticals to assure proper volume expansion and infiltration into the surgical site. The following techniques was developed by Tony Sanzone MD and Hank Hutchinson MD (EXPAREL PROTOCOL below). It is recommended that Medical Affairs be allowed to work with physicians in the study to assure proper technique and volume as EXPAREL is highly dependent on correct volume and technique into the surgical site, analysis should also look at age stratification. (Note: EXPAREL will not be provided by Pacira). Successful proposals will outline a program that achieves the following: Patient recruitment will be completed within a 15-month period from the time of funding. Multicenter studies are strongly encouraged to achieve this goal. No-cost extensions will be granted. Successful research proposals must outline a clear plan that demonstrates infrastructure is in place to achieve patient recruitment in the designated time period. Inclusion criteria: Patient sixty-five years of age and older, with isolated intra- or extra-capsular hip fractures undergoing ORIF (including intramedullary nailing) or arthroplasty Able to consent to the study Exclusion criteria: Pre-existing dementia Unable to consent to the study Patients undergoing closed reduction and percutaneous pinning of femoral neck fractures The following are suggested for primary outcomes: Delirium Scale (CAM) Total morphine equiv. post-surgery VAS pain scores Time to ambulate with physical therapy Secondary clinical measures: LOS Discharge Disposition (home vs. skilled nursing vs. inpatient rehab) 30 day readmission rates Any adverse event (AE) that leads to ICU admission or operation
Pacira-Grant-protocol-for-website.docx