The Local Infiltration Therapy (LIT) Trial for Pain Control Following Hip Fracture Fixation

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Geriatric hip fractures are an increasingly prominent public health problem with more than 300,000 fracture sustained within the U.S. each year and predicted over 1,000,000 by 2050. These fractures are life changing in elderly patients and sustaining a post-operative complication can be severely debilitating. Post-operative pain can be a significant driver of poor outcome via an increased risk of post-operative complications, including delirium which is associated with increased mortality, morbidity and outcome which persists beyond index hospitalization. Pain control is frequently managed with opioids which elderly patients are particularly susceptible to the negative side-effects they entail, which include somnolence, delirium, nausea, vomiting, urinary retention and respiratory depression. Additionally, increased opioid use in the context of the current opioid epidemic is further concerning and elderly patients are just as susceptible as other age groups. Thus, decreasing opioid use in these patients is paramount in decreasing complications and ultimately improving outcome for this deserving group of patients. In a pilot, double-blinded, multi-centered placebo-controlled trial we recently conducted, we reported a decreased use of opioids following hip fracture fixation and decreased pain visual analog scores (VAS) with the usage of liposomal bupivacaine. In a follow-up retrospective study, we demonstrated that the use of an injection cocktail of commonly available medications (Clonidine, Epinephrine, Ropivacaine, Toradol) demonstrated a similar and possibly greater decrease of opioid use and pain VAS when compared to liposomal bupivacaine. The injection cocktail is associated with less cost than the commercial liposomal bupivacaine and may be a more cost-effective alternative to liposomal bupivacaine. Given these findings and large support for both of these modalities in the arthroplasty literature, evaluation of the approach to improve outcomes in the hip fracture population is crucial to helping prevent complications and poor outcomes in these patients. This proposal aims to initiate and complete the planning of a multi-center, double-blind, non-inferiority trial with placebo for effect size determination to test our hypotheses that a pharmacy prepared cocktail is not inferior to a commercially available liposomal bupivacaine, and that local injection therapy can improve pain control following hip fracture fixation. We will utilize existing research relationships between clinical sites to complete the protocol, optimize procedures, prepare a budget, develop protocol forms, optimize recruitment procedures, develop a standard procedures manual, perform regulatory submissions and recruit additional sites as necessary to complete the proposed trial. Given the severity of complications associated with poor pain control, successful planning and completion of this trial can potentially introduce a method of pain control which is opioid free and widely adaptable with minimal resources.