Orthopaedic Trauma Association (OTA)



OTA/Pacira Directed Topic Proposal Research Grant Application Short InstructionsFunding Cycle June 1, 2017- December 31, 2018Application deadline: January 9, 2017The 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 arthroplastyAble to consent to the studyExclusion criteria:Pre-existing dementiaUnable to consent to the studyPatients undergoing closed reduction and percutaneous pinning of femoral neck fracturesThe following are suggested for primary outcomes:Delirium Scale (CAM) Total morphine equiv. post-surgeryVAS pain scores Time to ambulate with physical therapySecondary 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 operationComplications will be accurately documented.Eligibility: Either the principal investigator or co-principle investigator must be a member of the Orthopaedic Trauma AssociationFunding: Total funding is $50,000 (Two payments of $25,000 over 18-moths cycle) and will include direct and indirect costs. No salary support will be allowed for participating surgeons.EXPAREL PROTOCOL:Hank L. Hutchinson, MD Protocol:Technique for peri-articular injections in hemi-arthroplasty via direct anterior approach:Pre-operatively, IV acetaminophen, tranexamic acid, NSAIDs, and po narcotic are given.Direct anterior approach and hemi-arthroplasty are performed.Once implants are in place and confirmed to be appropriately placed by fluoroscopy, wound is copiously irrigated and final hemostasis is obtained. 50 cc of 0.025% Bupivacaine is first injected in a systematic fashion with self-retaining retractors holding the capsule open. Multiple 20cc syringes with 22 Ga spinal needles are used. Starting medially and posteriorly, the capsule is injected circumferentially in 10-12 locations with 2-3cc in each location, watching for the capsule to swell slightly. The posterior capsule is injected around the neck of the implant. Care is taken to ensure that the needle only penetrates the capsule 1-2 cm to prevent sciatic nerve or femoral nerve injury. The remaining Bupivacaine is then used to inject the direct head of the rectus femoris, sartorius, abductors, sartorius and tensor fascia lata. If any is remaining, the subcutaneous layer is injected. Exparel, diluted with 40cc of normal saline, for a total volume of 60cc is then injected in the same locations. Wound is then closed in standard fashion. As closure is begun, a second dose of tranexamic acid is given.Postoperatively, IV acetaminophen is given for 24 hours, NSAIDs are continued, and PO narcotics are given PRN with IV available for breakthrough if needed. Narcotics are only given in recovery room if needed. PCA’s are not used routinely. Patients are mobilized day of surgery if possible.Tony Sanzone MD Hemiarthroplasty Protocol:Use of Exparel in the Treatment of Femoral Neck Fractures with Hemiarthroplasty?A standard anteriorlateral approach to the hip is performed.? Once the prosthesis is implanted and appropriate?stability is achieved, wound closure is initiated.? Using #5 Ticron suture the hip capsule and abductor muscle is repaired?via drill holes in the greater trochanter.? Twenty-five cc's?of .5%?Marcaine is the inserted into?this layer as well as into the tensor fascia lata, subcutaneous tissue and skin.? This is then followed by Exparel diluted with 40cc of normal saline.? Specifically the abductor musculature, capsule and bone is injected with 20cc of solution.? Next the tensor fascia lata is closed and 20cc of solution is injected.? Finally the subcutaneous layer and skin are closed with 2-0 vicryl and staples respectively and the final 20cc of solution is used.? Dry dressings are then placed.? ................
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