A Pilot Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures

This submission contains a proposal for a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic “cocktail” in patients undergoing operative fixation of ankle fractures. We hypothesize that a long-acting local anesthetic agent will have similar improvements in pain as a regional block when compared with standard of care treatment while lowering costs and improving patient satisfaction. We plan to achieve this via the following Specific Aims: Specific Aim 1: Determine the effectiveness of a local anesthesia “cocktail” compared to regional block or standard of care in controlling pain in operatively treated ankle fractures. Nearly one out of ten fractures treated by both orthopaedic traumatologists and general orthopaedic surgeons taking call are ankle fractures. As such, effective pain control in this group of patients represents an opportunity to make a large impact, especially in the context of the current opiod epidemic. Improved pain control can help improve patient satisfaction, outcomes, decrease length of stay, cost of care, and complications associated with traditional narcotic use. • Hypothesis 1A: Patients receiving the intraoperative cocktail will have improved post-operative pain control compared to those receiving a peri-operative nerve block or standard of care. • Hypothesis 1B: Patients receiving the intraoperative cocktail or peri-operative nerve block will have improved post-operative pain control when compared to standard of care. • Null Hypothesis 1: There will be no difference in post-operative pain control between all treatment arms. Specific Aim 2: Determine the economic impact of cocktail and regional blocks in ankle fractures. A common concern with the use of regional blocks is the cost of the additional procedure, along with logistic delays which are associated with coordinating a separate procedure. This study would provide valuable data about the additional costs associated with regional blocks and with cocktail administration which could help aid in making economically conscious treatment decisions. • Hypothesis 2: Local cocktail administration will have significantly lower costs than regional block, and not be significantly more expensive than standard of care. • Null Hypothesis 2: There is no difference in cost between the modalities Specific Aim 3: Genrate pilot data supporting the use of long acting local anesthetic as a viable pain management strategy in fracture surgery. The power analysis for this study is based off literature-documented moderate effect sizes that have been shown in similar studies. However, in the event that the effect size is smaller, this study will serve as pilot data for application to larger, federally funded grants, ultimately helping grow the body of evidence for the use of long acting local anesthetic in orthopaedic trauma in general. • Hypothesis: Efficacy of long-acting local anesthetic cocktail in ankle fracture surgery could be translatable to other fields of orthopaedic trauma.